Given the widespread use of anticonvulsants in the pediatric chronic pain population and the absence of scientific data supporting their use, the investigators propose a randomized, double blind, two group parallel design in which a broad group of children and adolescents with chronic neuropathic pain would be randomized to receive either Gabapentin or Oxcarbazepine.
The Primary Aim of the Study is to assess the frequencies of successful treatment of pediatric patients with neuropathic pain treated with either Gabapentin or Oxcarbazepine.
The Primary Hypotheses are as follows:
Hypothesis I: Both Gabapentin and Oxcarbazepine will result in significant reduction in pain scores when compared to each patient's baseline.
Hypothesis II: Patients who continue on active drug (Gabapentin or Oxcarbazepine) during the second phase of the trial will report greater pain reduction relative to baseline than patients who are randomized onto placebo at this randomization point.
Secondary Aims of the Study are to compare groups treated initially with Gabapentin or Oxcarbazepine with regard to reduction in pain scores (both at rest and with evoked maneuvers), functional disability scores, tolerability, and measures of mood and cognitive functioning.
Secondary Hypotheses are that Gabapentin and Oxcarbazepine differ in their effects on:
1. Pain scores at rest and with evoked maneuvers
2. Functional disability scores
3. Tolerability (frequencies of side-effects)
4. Depression and anxiety scales
5. Neuropsychological measures of cognitive processing speed, working memory, and attention.

Start Date01 Oct 2024

Sponsor / Collaborator

The Children's Hospital Corp.

CTR20241440 / CompletedNot Applicable

奥卡西平口服混悬液（60mg/mL）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、四周期、完全重复交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of oxcarbazepine oral suspension (60 mg/mL) in Chinese healthy subjects under fasting and fed conditions

主要研究目的：按有关生物等效性试验的规定，选择Novartis Pharma Schweiz AG为持证商的奥卡西平口服混悬液（商品名：曲莱，规格：60mg/mL）为参比制剂，对浙江国镜药业有限公司生产，四川科伦药物研究院有限公司提供的受试制剂奥卡西平口服混悬液（规格：60mg/mL）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，比较两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂奥卡西平口服混悬液（规格：60mg/mL）和参比制剂奥卡西平口服混悬液（商品名：曲莱，规格：60mg/mL）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, oxcarbazepine oral suspension (trade name: Trileptin, specification: 60mg/mL) with Novartis Pharma Schweiz AG as the licensee was selected as the reference preparation, and the test preparation oxcarbazepine oral suspension (specification: 60mg/mL) produced by Zhejiang Guojing Pharmaceutical Co., Ltd. and provided by Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. was subjected to human bioequivalence test for fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to compare the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary research purpose: To observe the safety of the test preparation oxcarbazepine oral suspension (specification: 60mg/mL) and the reference preparation oxcarbazepine oral suspension (trade name: Trileptin, specification: 60mg/mL) in healthy subjects.

Start Date30 May 2024

Sponsor / Collaborator

Sichuan Kelun Pharmacy Institute Co., Ltd.

CTR20241444 / CompletedNot Applicable

奥卡西平口服混悬液（60mg/mL）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、四周期、完全重复交叉生物等效性预试验

[Translation] A randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence pilot study of oxcarbazepine oral suspension (60 mg/mL) in Chinese healthy subjects under fasting and fed conditions

按有关生物等效性试验的规定，选择Novartis Pharma Schweiz AG为持证商的奥卡西平口服混悬液（商品名：曲莱®，规格：60mg/mL（包装规格100mL））为参比制剂，对浙江上药九洲生物制药有限公司持证、上海中华药业有限公司生产的受试制剂奥卡西平口服混悬液（规格：60mg/mL）进行空腹和餐后给药人体生物等效性预试验，评估两制剂的药代动力学特征，为正式试验设计提供参考依据。

[Translation]

In accordance with the relevant provisions of bioequivalence tests, oxcarbazepine oral suspension (trade name: Trileptin®, specification: 60 mg/mL (packaging specification 100 mL)) licensed by Novartis Pharma Schweiz AG was selected as the reference preparation. The test preparation oxcarbazepine oral suspension (specification: 60 mg/mL) licensed by Zhejiang SPH Jiuzhou Biopharmaceutical Co., Ltd. and produced by Shanghai Zhonghua Pharmaceutical Co., Ltd. was subjected to a preliminary human bioequivalence study on fasting and postprandial administration to evaluate the pharmacokinetic characteristics of the two preparations and provide a reference for the formal trial design.

Start Date15 May 2024

Sponsor / Collaborator

Zhejiang Shangyao Jiuzhou Biopharmaceutical Co., Ltd.

100 Clinical Results associated with Oxcarbazepine

100 Translational Medicine associated with Oxcarbazepine

100 Patents (Medical) associated with Oxcarbazepine

2,439

Literatures (Medical) associated with Oxcarbazepine

01 Feb 2025·JOURNAL OF PHARMACY PRACTICE

The Phenytoin Ataxia Enigma Unveiled “A Case Report’’

Article

Author: Patel, Nishi ; Premal, Yatvi ; Khadela, Avinash ; Sadhwani, Devang ; Dave, Bhavarth

Background: Phenytoin (PHT) has been approved for the treatment of epilepsy. It belongs to the category of medications with a limited therapeutic window and requires therapeutic drug monitoring (TDM). PTH has been observed to induce a variety of Adverse drug reactions (ADRs) including ataxia, dystonia, nystagmus, dyskinesia, etc. Phenytoin-induced ataxia is an uncommonly observed ADR of Phenytoin whose reports are extremely limited. Case: Herein, we present a case report of a 16-year-old Asian patient with a past history of epilepsy that was admitted to a tertiary care hospital due to the development of ataxia, giddiness, and vomiting when taking Phenytoin in addition to Oxcarbazepine, Clobazam, and Levetiracetam to treat seizures. On admission, Magnetic resonance imaging (MRI) findings revealed bilateral variable cerebrospinal fluid (CSF) lesions in the parieto-occipital region of the periventricular area (periventricular leukomalacia). Additionally, serum Phenytoin levels were observed to be in the toxic range (40 μg/mL) due to which physicians confirmed the ADR to be due to Phenytoin toxicity. Thus, the Phenytoin drug was discontinued in the patient gradually and he was continued on clobazam, oxcarbazepine, and brivaracetam which led to reversal of the ADR in the patient. Conclusion: In this case, ataxia resulted from Phenytoin overdose, as confirmed by MRI and serum tests suggesting that TDM of Phenytoin is essential to prevent ADRs. Given the scarcity of ataxia cases caused by Phenytoin, awareness is lacking within the scientific community. Our aim is to provide insights to promote better monitoring and patient-centered treatment outcomes for epileptic patients.

01 Jan 2025·Radiology case reports

Delayed focal seizures following gunshot wound to the head in a child with minimal initial sequelae

Article

Author: Miller, Derryl ; Croxton, Amanda ; Singhal, Saurabh ; Walsh, Laurence

A 6 year old girl accidentally discovered a gun in her home and shot herself in her mouth. A bullet lodged in her right frontal lobe, but she remained neurologically intact with minimal symptoms. Her diagnosis was delayed due to the family leaving the emergency room for long wait times and later noticed over 72 hours from the injury at a dentist appointment. She was sent back to the emergency department, where head imaging revealed the injury to be inoperable. Six months later, the patient developed focal impaired awareness seizures. This was treated with oxcarbazepine, and patient responded well with no further spells. The case was highly unusual as the neurological symptoms were mild compared to the severity and the risk of initial intracranial injury. It emphasizes the frequently overlooked risk of leaving guns unsecured in households with children.

01 Dec 2024·MEDICINA CLINICA

Drug-induced hyponatraemia and possible related signals: Analysis of 659 cases reported to the Spanish Pharmacovigilance System and disproportionality analysis

Article

Author: Sainz-Gil, María ; Estévez Asensio, Lucía ; Fernández-Araque, Ana M. ; Verde Rello, Zoraida ; Velasco-González, Verónica ; Fernández-Araque, Ana M ; García, Montserrat

INTRODUCTION:

Hyponatraemia has negative effects on cognitive function and gait stability and is a risk factor for osteoporosis, falls, fractures and hospital mortality. Acute hyponatraemia can lead to neurological dysfunction due to cerebral oedema. Its rapid correction can also be fatal, leading to osmotic demyelination syndrome. For some antiepileptics, thiazides, benzodiazepines or antidepressants this reaction is widely described. Knowing which drugs are most likely to cause hyponatraemia will allow early detection and prevention of its complications, as well as individualising the prescription of these drugs according to the patient's characteristics.

OBJECTIVE:

The main objectives are to identify potential new safety signals related to hyponatraemia and to analyse the cases of hyponatraemia reported to the Spanish Pharmacovigilance System for Medicines for Human Use (SEFV-H).

METHOD:

A disproportionality and a descriptive analysis of individual case safety reports (ICSR) was performed in the SEFV-H database (FEDRA).

RESULTS:

Six hundred and fifty-nine cases of suspected drug-induced hyponatraemia were found (0.6% of the total database). Over the 5 years period studied, there was a 57% increase in the number of hyponatraemia reports in Spain. Most of the reported cases were serious (93%). Patients were most often women (63.7%) and elderly (71.9%). The time to onset ranged from 1 to 7030 days (median, 79 days) and approximately 70% of the total occurred within the first year of treatment. Five hundred and forty-six patients (82.9%) showed complete recovery after the withdrawal of the suspected medicine. Diuretics (reported in 57.7% of the cases), antidepressants (in 25%), drugs acting on renin angiotensin system (in 24%) and antiepileptics (in 20.2%) were the most frequent involved drugs. Disproportionate reporting has been found for almost all the substances most frequently reported, higher for amiloride and oxcarbazepine. Regarding new safety signals, the Reporting Odds Ratio (ROR) (95% CI) was found to be statistically significant for valsartan [7.7 (5.1-11.5)], olmesartan [7.3 (4.7-11.1)], amlodipine [3.4 (2.1-5.4)], pregabalin [2.5 (1.4-4.5)], irbesartan [18.6 (9.6-35.9)], paliperidone [2.7 (1.3-5.7)], ritonavir [2.4 (1.1-5.5)], atosiban [29.7 (8.6-102.2)], melphalan [9.7 (3.5-26.8)] and clozapine [4.4 (1.6-11.8)]. These active ingredients do not include this reaction on their SPC and comply with the EMA criteria for a safety signals.

CONCLUSION:

There are increasing reports of drug-induced hyponatraemia. It can be serious and seems to most often affect women over 65 years of age who take more than 1 medication. The time to onset varies and can be very long, so patient monitoring should be continuous throughout treatment. Hydrochlorothiazide is the drug with the highest number of reported cases in our setting. In terms of disproportionate reporting, diuretics leads the list, followed by antiepileptics as oxcarbazepine and eslicarbazepine. Safety signals were found for several drugs, more plausibly for pregabalin and paliperidone, thus a possible association between these drugs and hyponatraemia/SIAD is identified. This signal must be further studied. Meanwhile healthcare professionals should pay attention to this possibility. The reporting of suspected ADRs is essential to understand the risks associated with medicines once they are on the market.

News (Medical) associated with Oxcarbazepine

06 Dec 2024

·www.drugs.com

Many Women With Epilepsy Unaware of Seizure Meds' Risks to Pregnancy

FRIDAY, Dec. 6, 2024 -- Many women with epilepsy who are of childbearing age might not realize their anti-seizure drugs can raise the risk of birth defects or dampen the effectiveness of their birth control, a new study warns. Likewise, some birth control methods can cause anti-seizure meds to be less effective, researchers reported Friday in a presentation at the annual meeting of the American Epilepsy Society in Los Angeles. “Many neurologists do not learn about birth control in their training, even though they know that anti-seizure medications may have some risks in pregnancy,” said senior researcher Dr. Sarah Betstadt , an associate professor of obstetrics and gynecology at the University of Rochester Medical Center. “We hope this study raises awareness for patients and encourages health care providers from neurology and reproductive health care to work together to ensure the best care for these patients,” Betstadt added in a society news release. For the study, researchers surveyed 107 women ages 18 to 49 who were taking anti-seizure medications about their reproductive plans. Six said they were pregnant or planning to become pregnant, and another 69 said they were using some sort of birth control that could interfere with their anti-seizure meds, researchers said. The survey quizzed women on their knowledge regarding birth control and anti-seizure meds, and found that: “Survey participants may not have known that their answers were wrong and so did not feel they needed more information,” Betstadt noted. Only about a third of the women were receiving medical care that aligned with their reproductive plans, researchers found. Anti-seizure medications that increase the risk of birth defects include valproic acid , topiramate , carbamazepine , phenobarbital and phenytoin. Further, anti-seizure drugs that can make hormonal contraceptives like pills, patches and rings less effective include carbamazepine, phenytoin , phenobarbital, and higher doses of topiramate and oxcarbazepine . Despite that, no anti-seizure drug is as dangerous for an expecting mother or her fetus as uncontrolled seizures , the researchers noted. Women who want to become pregnant should talk with their doctor about drugs that are less risky but still can control their seizures, researchers said. “Neurology and reproductive health care providers should collaborate to provide the safest and most effective care for their patients of reproductive age who are taking anti-seizure medications,” Betstadt said. “This collaboration can help patients navigate their reproductive choices while minimizing drug-drug interactions that may reduce the effectiveness of seizure medications and/or birth control methods,” Betstadt added. Findings presented at medical meetings should be considered preliminary until they’re published in a peer-reviewed journal. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

16 Oct 2024

·www.businesswire.com

ViiV Healthcare Shows More Than 99% Effectiveness in Real-World Studies for Apretude (Cabotegravir Long-Acting), the Only Approved Long-Acting HIV PrEP, in Data Presented at IDWeek 2024

LONDON--( BUSINESS WIRE )--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the presentation of new real-world evidence and implementation data showing the effectiveness, adherence, and quality-of-life improvement of Apretude (cabotegravir long-acting (CAB LA)) for HIV pre-exposure prophylaxis (PrEP). The data will be presented at IDWeek 2024 , being held in Los Angeles, California from 16 – 19 October. Findings from two real-world evidence studies (from OPERA and Trio Health cohorts) showed more than 99% effectiveness of CAB LA for PrEP in nearly 1,300 individuals. In the PILLAR implementation study, reductions were shown in stigma and anxiety among the 200 individuals using the long-acting injectable PrEP option. Harmony P. Garges, M.D., MPH, Chief Medical Officer at ViiV Healthcare, said: “The findings presented at IDWeek 2024 continue to support the strong and sustained effectiveness of Apretude for people in real life, outside the controlled environment of a clinical trial. The results of the studies from OPERA and Trio cohorts add to the growing body of evidence generated over the last three years, showing CAB LA for PrEP is a highly effective option for HIV prevention. We believe long-acting options have the potential to be transformative in increasing uptake among a broad range of people that could benefit from PrEP and are critical to ending the HIV epidemic.” Trio Health cohort shows CAB LA for PrEP’s effectiveness in the real world with zero cases of HIV acquisition during follow-up 1 New data from the Trio Health cohort shows the real-world use of CAB LA for PrEP in preventing HIV acquisition and adherence, among 474 individuals in the U.S. The analysis identified a diverse population of cis- and transgender male and female individuals initiating CAB LA for PrEP from electronic health records between December 2021 through January 2024. Findings from the cohort showed that there were zero HIV diagnoses identified during follow-up among participants taking CAB LA for PrEP. Eighty-three percent persisted on CAB LA for PrEP injections at the time of analysis, and injections were also administered on time for most of the initiators. Of the 396 participants with continuation injections, 33% experienced delays with a median of one delayed injection and median delay of 12 days [IQR: 3-29]. Adherence to CAB LA for PrEP was high, with only 3% of participants experiencing a missed injection. OPERA study highlights high adherence and effectiveness of CAB LA for PrEP 2 Real-world findings from the OPERA study provide insights into injection timing, adherence, and effectiveness among individuals using CAB LA for PrEP in the U.S.. The OPERA study reported findings from a large, diverse U.S. cohort, which included 764 individuals using CAB LA for PrEP, 29% of whom are Black and 29% Hispanic. CAB LA for PrEP was effective in 99.7% of individuals (762 of 764 were not diagnosed with HIV during the follow-up period). There were two cases of HIV (0.3%) observed among the CAB LA for PrEP initiators. These cases could not be directly linked to the regimen due to its discontinuation in one case and inconsistent testing in the other case. Eighty-five percent of individuals taking CAB LA for PrEP had complete initiation of the regimen (i.e. completed their first two initiation injections 60 or less days apart from each other). Sixty-nine percent of these complete initiators received all of their continuation injections on time. While some injection delays were observed among those with complete initiation, most were short, with a median delay of three days from the target date. PILLAR implementation study shows CAB LA for PrEP may help address key PrEP challenges of stigma and anxiety 3 New findings from the PILLAR trial explore the experiences of more than 200 men who have sex with men (MSM) and transgender men (TGM) who initiated CAB LA for PrEP after previous experience with daily oral PrEP. PILLAR is a phase 4 implementation trial assessing the integration of CAB LA for PrEP across 17 U.S. clinics among a diverse population of MSM and TGM, 23% of whom are Black and 39% Hispanic/Latino. The six-month findings from the PILLAR trial showed that individuals taking CAB LA for PrEP reported lower rates of PrEP stigma and anxiety compared to their prior oral PrEP experience, and that the long-acting injectable was feasible, acceptable, and convenient for their life. When recounting their oral PrEP experience at the initiation of the trial, 15% of participants had worried about privacy while taking oral PrEP, 24% felt they had to hide their oral PrEP from others, and 29% expressed worry about stigma from taking oral PrEP. After initiating CAB LA for PrEP and completing surveys at month six of the trial, <1% of participants reported concerns about privacy and only 1% expressed worry about stigma while taking CAB LA for PrEP. Participants who completed interviews noted CAB LA for PrEP reduced the stress and fear of missing a PrEP dose, while offering confidence of protection from HIV. While 45% of participants reported injection site reactions (ISRs), 86% of participants returned to daily activities the same day and few reported being bothered by injection pain (8%). These individuals who had been initially bothered by injection pain reported that pain decreased over subsequent injections. CAB LA for PrEP demonstrated high levels of acceptability among users, with mean acceptability scores increasing from 4.4 at baseline (SD: 0.69) to 4.6 at six months (SD: 0.61), with interviewees noting that CAB LA for PrEP was convenient for their life. This positive experience was supported by flexible clinic scheduling, transportation assistance, and the use of virtual appointments, all of which were identified as valuable facilitators of adherence. These studies demonstrate ViiV Healthcare's commitment to generating robust real-world evidence for CAB LA for PrEP, furthering the study of its implementation, and advancing the understanding of its impact on diverse communities who can benefit from HIV prevention. Further research will continue to explore the long-term benefits of CAB LA for PrEP and optimise its use. APRETUDE (cabotegravir) extended-release injectable suspension P rofessional Indication and Important Safety Information INDICATION APRETUDE is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP. IMPORTANT SAFETY INFORMATION BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen. CONTRAINDICATIONS Do not use APRETUDE in individuals: with unknown or positive HIV-1 status with previous hypersensitivity reaction to cabotegravir receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine WARNINGS AND PRECAUTIONS Comprehensive Management to Reduce the Risk of HIV-1 Infection: Use APRETUDE as part of a comprehensive prevention strategy, including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition. Risk for HIV-1 acquisition includes, but is not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner[s] HIV-1 status, including viral suppression status; regular testing for STIs) Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment. Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs Additional HIV testing to determine HIV status is needed if an HIV-1 test indicates possible HIV-1 infection or if symptoms consistent with acute HIV-1 infection develop following an exposure event. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment Counsel individuals without HIV-1 to strictly adhere to the recommended dosing and testing schedule for APRETUDE Potential Risk of Resistance with APRETUDE: There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to test before each injection to confirm HIV-1–negative status. Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment. If individuals at continuing risk of HIV-1 acquisition discontinue APRETUDE, alternative forms of PrEP should be considered and initiated within 2 months of the final injection of APRETUDE Long-Acting Properties and Potential Associated Risks with APRETUDE: Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence or missed doses could lead to HIV-1 acquisition and development of resistance Hypersensitivity Reactions: Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with APRETUDE Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated Hepatotoxicity: Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated Depressive Disorders: Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicidal ideation or attempt) have been reported with APRETUDE Promptly evaluate patients with depressive symptoms Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions: The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE ADVERSE REACTIONS The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection. DRUG INTERACTIONS Refer to the full Prescribing Information for important drug interactions with APRETUDE Drugs that induce UGT1A1 may significantly decrease the plasma concentrations of cabotegravir USE IN SPECIFIC POPULATIONS Lactation: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation Pediatrics: Not recommended in individuals weighing less than 35 kg About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q2 Results for 2024. Registered in England & Wales: GSK plc No. 3888792 ViiV Healthcare Limited No. 06876960 Registered Office: 79 New Oxford Street London WC1A 1DG ViiV Healthcare Limited GSK Medicines Research Centre Gunnels Wood Road, Stevenage United Kingdom SG1 2NY References 1. M Ramgopal, et al. Real-world use of cabotegravir long-acting for pre-exposure prophylaxis: Data from Trio Health cohort. Presented at the Infectious Disease society of America (IDSA) IDWeek™ 2024, 16-19 October, Los Angeles, CA. 2. R Hsu, et al. Cabotegravir Long-Acting for Pre-Exposure Prophylaxis (PrEP): Real World Data on On-Time Dosing, HIV Testing and HIV Acquisition from the OPERA Cohort. Presented at the Infectious Disease society of America (IDSA) IDWeek™ 2024. October 2024. 3. H. Holder, et al. Patient Experiences at Month 6 after Initiation of Cabotegravir Long-Acting (CAB LA) for PrEP in the First Male Gender Concordant Implementation Science Trial (PILLAR) in the US. Presented at the Infectious Disease society of America (IDSA) IDWeek™ 2024. October 2024.

Clinical ResultPhase 3

06 Aug 2024

·www.globenewswire.com

Supernus Announces Second Quarter 2024 Financial Results

Net sales of Qelbree® increased 92% in the second quarter of 2024, compared to the same period in 2023. $59.4 million and $104.5 million of net sales in the second quarter and first six months of 2024, respectively. Net sales of GOCOVRI® increased 10% in the second quarter of 2024, compared to the same period in 2023. $31.7 million and $58.3 million of net sales in the second quarter and first six months of 2024, respectively. Total revenues were $168.3 million in the second quarter of 2024, an increase of 24% compared to the same period in 2023. Total revenues excluding Trokendi XR® and Oxtellar XR® net product sales (non-GAAP)(1) increased 32% in the second quarter of 2024, compared to the same period in 2023. Operating income of $22.6 million and $19.4 million in the second quarter and first six months of 2024.Adjusted operating earnings (non-GAAP)(1) was $45.5 million and $67.7 million in the second quarter and first six months of 2024, respectively, compared to $10.0 million and $40.5 million in the same periods in 2023.Raising full year 2024 guidance for total revenues and operating earnings (GAAP and Non-GAAP). ROCKVILLE, Md., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the second quarter of 2024 and associated Company developments. Business Highlights Total IQVIA prescriptions for Qelbree were 184,342 in the second quarter 2024, an increase of 26% compared to the same period in the prior year.In August 2024, the Company resubmitted its New Drug Application (NDA) for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations ("off" episodes) in Parkinson’s disease. “In the second quarter of 2024, we delivered strong net sales growth from our key growth drivers, Qelbree and GOCOVRI, as well as strong growth in adjusted operating earnings. We also advanced our product pipeline, announcing interim results from our open-label Phase 2a clinical study of SPN-817 for treatment-resistant seizures, and continued to progress SPN-820 through two Phase 2 studies in patients with depression," said Jack Khattar, President and CEO of Supernus. “Continued growth from Qelbree and GOCOVRI, together with pipeline progress, gives us confidence in delivering on our increased guidance and our operational objectives for 2024." Product Pipeline Update SPN-820 – Novel first-in-class molecule that increases mTORC1 mediated synaptic function for depression Nearly three-quarters of the planned patients have been enrolled in the ongoing Phase IIb multi-center randomized double-blind placebo-controlled parallel design study of SPN-820 in adults with treatment-resistant depression. The study will examine the efficacy and safety of SPN-820 over a course of five weeks of treatment in approximately 268 patients in up to 50 clinical sites. The primary outcome measure is the change from baseline to end of treatment period on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. Topline data from the Phase IIb trial are expected in the first half of 2025.Enrollment is ongoing in the Phase II open-label study in patients with major depressive disorder (MDD). The primary objective of the study is to assess efficacy in MDD, as well as onset of efficacy. Topline results from the study are expected by the end of 2024. SPN-817 – Novel first-in-class highly selective AChE inhibitor for epilepsy In May 2024, the Company announced data from the planned interim analysis of its exploratory open-label Phase IIa clinical study of SPN-817 for treatment-resistant seizures. The interim analysis was based on 41 enrolled subjects, of which 19 completed the maintenance period. The Company continues to expect topline results for the full study in the second half of 2024. A Phase IIb randomized, double-blind, placebo-controlled study in patients with treatment resistant focal seizures is expected to start by the end of 2024. SPN-443 – Novel stimulant for ADHD/CNS The Company plans to initiate a Phase I single dose study in healthy adults in 2024 following submission of an Investigational New Drug application. The primary objective of the study is to assess safety and tolerability. Financial Highlights This section includes information on non-GAAP financial measures. See “Non-GAAP Financial Information” section for information on non-GAAP financial measures. In addition, a reconciliation of applicable GAAP to non-GAAP financial information is included at the end of this press release. Revenues The following table provides information regarding total revenues (dollars in millions): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 Change % 2024 2023 Change %Net product sales Qelbree$59.4 $31.0 92% $104.5 $56.8 84%GOCOVRI 31.7 28.8 10% 58.3 54.8 6%Oxtellar XR 29.5 23.8 24% 56.5 52.7 7%APOKYN 17.3 17.6 (2)% 33.9 34.8 (2)%Trokendi XR 17.1 19.3 (12)% 33.1 54.1 (39)%Other(2) 7.5 7.8 (4)% 14.7 15.7 (6)%Total net product sales 162.5 128.3 27% 301.0 268.9 12%Royalty, licensing and other revenues(3) 5.8 7.2 (20)% 11.0 20.4 (46)%Total revenues$168.3 $135.5 24% $312.0 $289.3 8% Total revenues excluding Trokendi XR and Oxtellar XR net product sales (non-GAAP)(1)$121.7 $92.4 32% $222.4 $182.5 22% Total revenues were $168.3 million and $312.0 million for the three and six months ended June 30, 2024, compared to $135.5 million and $289.3 million in the same period in 2023. Total net product sales were $162.5 million and $301.0 million for the three and six months ended June 30, 2024, compared to $128.3 million and $268.9 million in the same period in 2023, respectively. The increase in both periods was primarily due to the increase in net sales of Qelbree, GOCOVRI and Oxtellar XR, partially offset by the decline in net product sales of Trokendi XR due to generic erosion.Total revenues excluding Trokendi XR and Oxtellar XR net product sales (non-GAAP) increased 32% and 22% for the three and six months ended June 30, 2024, compared to the same period in 2023. Other Financial Highlights Operating earnings was $22.6 million and $19.4 million for the three and six months ended June 30, 2024, compared to operating loss of $(17.6) million and $(12.4) million for the same periods in 2023, respectively. The positive increase in both periods was primarily due to an increase in total net product sales.Adjusted operating earnings (non-GAAP) were $45.5 million and $67.7 million for the three and six months ended June 30, 2024, compared to $10.0 million and $40.5 million for the same periods in 2023, respectively.Net earnings (loss) and diluted earnings (loss) per share were $19.9 million and $0.36 for the three months and $20.0 million and $0.36 for the six months ended June 30, 2024, respectively, compared to $(0.8) million and $(0.02) for the three months and $16.1 million and $0.29 for the six months ended June 30, 2023, respectively.At June 30, 2024, cash, cash equivalents, and current and long-term marketable securities were approximately $347.2 million compared to $271.5 million as of December 31, 2023. This increase was primarily due to cash generated from operations. Full Year 2024 Financial Guidance For the full year 2024, the Company is increasing prior financial guidance for total revenues, GAAP operating earnings (loss) and non-GAAP operating earnings, and maintaining guidance for combined R&D and SG&A expenses as set forth below (dollars in millions). Current Guidance(as of August 6, 2024) Previous Guidance(as of May 8, 2024)Total revenues (includes approximately $135 - $145 million of Trokendi XR and Oxtellar XR)(4)(5)$600 - $625 $580 - $620Combined R&D and SG&A expenses$430 - $460 $430 - $460Operating earnings (loss)$0 - $20 $(30) - $(0)Adjusted operating earnings (non-GAAP)(1)$100 - $125 $80 - $110 Non-GAAP Financial Information This press release contains financial measures that present financial information which do not comply with United States generally accepted accounting principles (GAAP). The non-GAAP financial measures should be considered in addition to, not as a substitute for or in isolation from, or superior to measures prepared in accordance with GAAP. Non-GAAP adjusted operating earnings on a historical and projected basis adjusts for non-cash share-based compensation expense, depreciation and amortization, intangible asset impairment charges and changes to fair value of contingent consideration, and for factors that are unusual, non-recurring or unpredictable, and excludes those costs, expenses, and other specified items presented in the reconciliation tables in this press release. In addition to non-GAAP adjusted operating earnings, we also present total revenues excluding net product sales of Trokendi XR (GAAP) and Oxtellar XR (GAAP), which is a non-GAAP measure and is calculated as total revenues (GAAP) less net product sales of Trokendi XR (GAAP) and Oxtellar XR (GAAP). Beginning in the year a product loses exclusivity due to generic entrants we generally do not expect net product sales of such products to constitute a significant part of our revenue in the future. We believe that the use of non-GAAP financial measures provides useful supplemental information to management, investors, analysts and others regarding the Company’s revenue and results of operations and assist management, investors, analysts, and others in understanding and evaluating our revenue growth and the performance of the business. There are limitations associated with the use of non-GAAP financial measures and therefore comparability may be limited. These limitations include: non-GAAP financial measures that may not be entirely comparable to similarly titled measures used by other companies; these may not reflect all items of income and expense, as applicable, that affect our operations; there may be potential differences among calculation methodologies; these may differ from the non-GAAP information used by other companies, including peer companies. We mitigate these limitations by reconciling the non-GAAP financial measure to the most comparable GAAP financial measure. Investors are encouraged to review the reconciliation. The Company’s 2024 financial guidance is also being provided on both a GAAP and a non-GAAP basis. End Notes (1) See the section titled “Non-GAAP Financial Information” for information about this non-GAAP financial measure. A reconciliation of each non-GAAP financial measure to the most directly comparable GAAP financial measure is included at the end of this press release.(2) Includes net product sales of MYOBLOC®, XADAGO® and Osmolex ER®.(3) Royalty, licensing, and other revenues include royalties on generic Trokendi XR, other licensed products and intellectual property.(4) Includes net product sales and royalty, licensing, and other revenue.(5) Reflects continued generic erosion of Trokendi XR and generic erosion of Oxtellar XR beginning in September 2024. Conference Call Details Supernus will host a conference call and webcast today, August 6, 2024, at 4:30 p.m. Eastern Time to discuss these results. A live webcast will be available in the Events & Presentations section of the Company’s Investor Relations website www.supernus.com/Investors. Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time. Following the live call, a replay will be available on the Company's Investor Relations website www.supernus.com/Investors. The webcast will be available on the Company’s website for 60 days following the live call. About Supernus Pharmaceuticals, Inc. Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD, hypomobility in Parkinson's disease (PD), cervical dystonia, chronic sialorrhea, and dyskinesia in PD patients receiving levodopa-based therapy. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders. For more information, please visit www.supernus.com. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products and the products of its subsidiaries; the Company’s ability to increase its net revenue from its products and the products of its subsidiaries; the Company’s ability to commercialize its products and the products of its subsidiaries; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates; the Company’s ability to protect its intellectual property and the intellectual property of its subsidiaries and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; and other risk factors set forth from time to time in the Company’s filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events. Supernus Pharmaceuticals, Inc.Condensed Consolidated Balance Sheets(in thousands, except share data) June 30, December 31, 2024 2023 (unaudited) Assets Current assets Cash and cash equivalents$52,089 $75,054 Marketable securities 295,098 179,820 Accounts receivable, net 152,494 144,155 Inventories, net 68,155 77,408 Prepaid expenses and other current assets 23,166 16,676 Total current assets 591,002 493,113 Long-term marketable securities — 16,617 Property and equipment, net 12,274 13,530 Intangible assets, net 559,644 599,889 Goodwill 117,019 117,019 Other assets 35,890 37,505 Total assets$1,315,829 $1,277,673 Liabilities and stockholders’ equity Current liabilities Accounts payable and accrued liabilities$82,611 $79,569 Accrued product returns and rebates 175,119 154,274 Contingent consideration, current portion 47,303 52,070 Other current liabilities 3,623 4,283 Total current liabilities 308,656 290,196 Contingent consideration, long-term 697 1,380 Operating lease liabilities, long-term 30,294 33,196 Deferred income tax liabilities, net 11,440 24,963 Other liabilities 7,288 6,422 Total liabilities 358,375 356,157 Stockholders’ equity Common stock, $0.001 par value; 130,000,000 shares authorized; 55,046,049 and 54,723,356 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively 55 55 Additional paid-in capital 455,170 439,493 Accumulated other comprehensive loss, net of tax (372) (593)Retained earnings 502,601 482,561 Total stockholders’ equity 957,454 921,516 Total liabilities and stockholders’ equity$1,315,829 $1,277,673 Supernus Pharmaceuticals, Inc.Condensed Consolidated Statements of Earnings (Loss)(in thousands, except share and per share data) Three Months EndedJune 30, Six Months EndedJune 30, 2024 2023 2024 2023 (unaudited) (unaudited)Revenues Net product sales$162,538 $128,336 $300,999 $268,911 Royalty, licensing and other revenues 5,787 7,227 10,970 20,416 Total revenues 168,325 135,563 311,969 289,327 Costs and expenses Cost of goods sold(a) 17,916 21,091 34,225 44,551 Research and development 26,183 24,379 51,113 45,591 Selling, general and administrative 85,904 86,782 172,420 172,379 Amortization of intangible assets 20,108 20,108 40,245 40,074 Contingent consideration expense (gain) (4,355) 790 (5,450) (857)Total costs and expenses 145,756 153,150 292,553 301,738 Operating earnings (loss) 22,569 (17,587) 19,416 (12,411) Other income (expense) Interest and other income, net 3,733 1,370 7,129 6,716 Interest expense — (910) — (2,415)Total other income (expense) 3,733 460 7,129 4,301 Earnings (loss) before income taxes 26,302 (17,127) 26,545 (8,110) Income tax expense (benefit) 6,386 (16,296) 6,505 (24,227)Net earnings (loss)$19,916 $(831) $20,040 $16,117 Earnings (loss) per share Basic$0.36 $(0.02) $0.37 $0.30 Diluted$0.36 $(0.02) $0.36 $0.29 Weighted average shares outstanding Basic 54,978,781 54,502,993 54,890,265 54,442,463 Diluted 55,724,283 54,502,993 55,675,474 59,035,154 (a) Excludes amortization of intangible assets. Supernus Pharmaceuticals, Inc.Reconciliations of GAAP to Non-GAAP Financial Information(Unaudited) Reconciliation of GAAP Total revenues to Non-GAAP Total revenues excluding Trokendi XR and Oxtellar XR net product sales An itemized reconciliation between total revenues on a GAAP basis and Total revenues excluding Trokendi XR and Oxtellar XR net product sales, a non-GAAP measure, is as follows (dollars in millions): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 Change % 2024 2023 Change %Total revenues (GAAP)(1)$168.3 $135.5 24% $312.0 $289.3 8%Adjustments: Trokendi XR net product sales (17.1) (19.3) (12)% (33.1) (54.1) (39)%Oxtellar XR net product sales (29.5) (23.8) 24% (56.5) (52.7) 7%Total revenues excluding Trokendi XR and Oxtellar XR net product sales (non-GAAP)(1)$121.7 $92.4 32% $222.4 $182.5 22% (1) Includes net product sales and royalty, licensing, and other revenues. Reconciliation of GAAP Operating earnings (loss) to Non-GAAP Adjusted Operating earnings An itemized reconciliation between operating earnings (loss) on a GAAP basis and adjusted operating earnings on a non-GAAP basis is as follows (dollars in millions): Three Months EndedJune 30, Six Months EndedJune 30, 2024 2023 2024 2023 Operating earnings (loss) - As Reported (GAAP)$22.6 $(17.6) $19.4 $(12.4)Adjustments: Amortization of intangible assets 20.1 20.1 40.2 40.1 Share-based compensation 6.6 6.1 12.4 12.4 Contingent consideration expense (gain) (4.4) 0.8 (5.5) (0.9)Depreciation 0.6 0.6 1.2 1.3 Operating earnings - As Adjusted (non-GAAP)$45.5 $10.0 $67.7 $40.5 Non-GAAP adjusted operating earnings adjusts for non-cash items including amortization of intangible assets, share-based compensation expense, change in fair value of contingent consideration, and depreciation. Reconciliation of Full Year 2024 Financial Guidance - GAAP Operating earnings (loss) to Non-GAAP Adjusted Operating earnings An itemized reconciliation between projected operating earnings (loss) on a GAAP basis for the full year 2024 and projected adjusted operating earnings on a non-GAAP basis for the full year 2024 is as follows (dollars in millions): Current Guidance(as of August 6, 2024) Previous Guidance(as of May 8, 2024)Operating earnings (loss) - GAAP$0 - $20 $(30) - $0Adjustments: Amortization of intangible assets$78 - $80 $80 - $81Share-based compensation$27 - $29 $27 - $29Contingent consideration expense (gain)$(7) - $(7) $1 - $2Depreciation$2 - $3 $2 - $3Operating earnings - As Adjusted (non-GAAP)$100 - $125 $80 - $110 CONTACTS: Jack A. Khattar, President and CEOTimothy C. Dec, Senior Vice President and CFOSupernus Pharmaceuticals, Inc.(301) 838-2591 or INVESTOR CONTACT:Peter VozzoICR Westwicke(443) 213-0505peter.vozzo@westwicke.com

Phase 2Financial StatementPhase 1

100 Deals associated with Oxcarbazepine

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KEGG	Wiki	ATC	Drug Bank
D00533	Oxcarbazepine	N03AF02	DB00776

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Approved

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Indication	Country/Location	Organization	Date
Seizures	CN	Novartis Pharma Schweiz AG	20 Jun 2003
Epilepsies, Partial	US	Novartis Pharmaceuticals Corp.	14 Jan 2000
Epilepsy	US	Novartis Pharmaceuticals Corp.	14 Jan 2000

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple Sclerosis	Phase 2	GB	Novartis Pharmaceuticals Corp.	01 Oct 2014

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EURAP registry (IEC2023)	Not Applicable	Congenital Abnormalities	9,840	Valproate	xvcaciocce(guuadmznet) = ljzyzoygjf sdcprkneqq (yebtjopqdp )	Positive	04 Sep 2023
				Phenytoin	xvcaciocce(guuadmznet) = soubmyenvl sdcprkneqq (yebtjopqdp )
EAN	Not Applicable	Epilepsies, Partial	89	Oxcarbazepine <1,200mg/day	ixpwbmizxp(uuythricsz) = besdakwjoh xqtzrzpadf (dwmvgxxerv )	Positive	18 Jun 2021
				Oxcarbazepine 1,200mg/day	ixpwbmizxp(uuythricsz) = akdbjrceil xqtzrzpadf (dwmvgxxerv )
AAN2020	Not Applicable	Familial Paroxysmal Dystonia First line	9	Oxcarbazepine	ijilnmieln(rmbosllmwb) = ccjylrvnnq geajfbionq (gglasrjlgh ) View more	-	14 Apr 2020
AAN2018	Not Applicable	-	529	Oxtellar XR	zgxnrshppr(hbszvbmigq) = rqgiyzxwja mxjhrnxgpy (sjrwwrbqhg )	-	10 Apr 2018
				Immediate-Release Oxcarbazepine (OXC-IR)	zgxnrshppr(hbszvbmigq) = fpsmelwhtx mxjhrnxgpy (sjrwwrbqhg )
NCT01891890 (COPE, CTgov)	Phase 3	Epilepsies, Partial	72	Lamotrigine (Lamotrigine)	cknvamvjab(wztduxtygq) = zuekvbjlht kjpjonzhyu (kslzkmdkpf, rqdhjhbqke - xjtbvqhyyo) View more	-	19 Sep 2017
				Oxcarbazepine (Oxcarbazepine)	cknvamvjab(wztduxtygq) = lncviqfelx kjpjonzhyu (kslzkmdkpf, zzfxhkhldh - hnfuyyhfys) View more
IEC2017	Not Applicable	-	392	Valproates	llvulxfrur(zmhbcicfah): RR = 0.85 (95% CI, 0.64 - 1.13)	Positive	04 Sep 2017
				Carbamazepine
NCT00908349 (CTgov)	Phase 3	Epilepsies, Partial	214	Oxcarbazepine XR	qqposgjiwr(ievkvsgnug) = vihafyxicy ffwcyqcmmw (grazbkxord, kqsxbckkbs - oomwwaexdy) View more	-	31 May 2017
AAN2017	Not Applicable	-	28	Oxtellar XR 1200 mg	awajdygglw(dvdlvqctba) = obttstwght azredvcrwc (cyfvdqeksy ) View more	-	18 Apr 2017
IEC2015	Not Applicable	Seizures	606	Oxcarbazepine oral suspension	gisldmidmk(eqtdkrjfle) = Skin and subcutaneous tissue disorders were the most frequently reported AEs and had 19 occurrences zfxejkndha (ylahhvlcaa ) View more	Positive	08 Sep 2015
EAN	Not Applicable	Epilepsy	307	Oxcarbazepine	ohhgwcistk(rooqxmvmeu) = dvwalfyknz opzdmqcenu (gwklezppem ) View more	Positive	29 Jun 2015
				Levetiracetam	ohhgwcistk(rooqxmvmeu) = fubvqlqsza opzdmqcenu (gwklezppem ) View more

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