HTR3B

New patent covers a treatment method for a broad spectrum of alcohol-related disorders, including additional conditions associated with alcohol useGLEN ALLEN, Va., May 01, 2025 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced patent number 12,274,692 was issued on April 15, 2025 by the United States Patent and Trademark Office (USPTO) covering a novel method of treating alcohol-related diseases and opioid-related disorders using AD04 in genetically identified patients. This newly issued patent strengthens Adial’s intellectual property portfolio by covering the administration of AD04, the Company’s investigational drug, as a precision medicine approach for patients with specific genetic markers. The patent claims a method of treating addiction by administering a therapeutically effective amount of AD04 to patients with serotonin-related gene variations, including specific genotypes of HTR3A, HTR3B, and SLC6A4, such as the LL genotype of 5-HTTLPR in combination with variations in rs1150226, rs17614942, and rs1176713. The granted claims include specific genetic profiles associated with treatment efficacy and the corresponding dosing regimens. Specifically for AUD, the patent claims cover a method of treatment for a broad definition of alcohol related disorders including, but not limited to, disorders associated with alcohol use such as alcohol induced or associated anxiety, bi-polar, sexual dysfunction, sleep disorder, or gambling disorder as well as alcohol withdrawal. “This patent represents yet another significant milestone for Adial Pharmaceuticals as we advance our mission to provide targeted treatments for individuals suffering from alcohol and opioid use disorders,” said Cary Claiborne, Chief Executive Officer of Adial Pharmaceuticals. “By identifying genetic markers associated with AD04 response, we are pioneering a precision medicine approach for AUD that has the potential to enhance treatment efficacy and improve patient outcomes. We remain committed to advancing AD04 through clinical development and regulatory pathways to address the urgent need for effective, personalized addiction treatments.” About Adial Pharmaceuticals, Inc. Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of therapies for the treatment and prevention of addiction and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company’s ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes identified using the Company’s proprietary companion diagnostic genetic test. ONWARD showed promising results in reducing heavy drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at www.adial.com. If you are interested in exploring partnership opportunities with Adial, we invite you to reach out to us (BD@adialpharma.com) to discuss how our joint efforts can bring about positive change to the millions of patients who are struggling with addiction. Forward-Looking Statements This communication contains certain "forward-looking statements" within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could" are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding advancing the Company’s mission to provide targeted treatments for individuals suffering from alcohol and opioid use disorders; and identifying genetic markers associated with AD04 response having the potential to enhance treatment efficacy and improve patient outcomes for AUD. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, future AD04 trials supporting AUO 4’s ability to enhance treatment efficacy and improve patient outcomes for AUD; our ability to pursue our regulatory strategy, our ability to advance ongoing partnering discussions, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law. Contact:Crescendo Communications, LLCDavid Waldman / Alexandra SchiltTel: 212-671-1020Email: ADIL@crescendo-ir.com

GLEN ALLEN, Va., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced patent number 12150931 was issued on November 26, 2024 by the United States Patent and Trademark Office, expanding the Company’s intellectual property coverage. The patent covers a broader range of genotype combinations identified by the Company’s proprietary genetic diagnostic for targeted treatment of alcohol use disorder (AUD) with AD04, the Company’s lead investigational new drug product. These genotype combinations include the HTR3A, HTR3B, and SLC6A4 receptor sites which are expected to play an important role in the Company’s precision medicine approach to treating addiction and may support the expansion of its pipeline. “This patent significantly enhances our intellectual property portfolio, providing us with greater flexibility and protection as we advance AD04 toward commercialization,” said Cary Claiborne, CEO of Adial Pharmaceuticals. “We are broadening our patent estate for AD04 and its use in the field of personalized medicine by securing expanded coverage of these genotype combinations. This granted patent is an important part of our strategy to protect AD04 for the treatment of AUD by patenting all possible combinations of genotypes identified in the clinical program and strengthening our IP protection through 2031. The goal is to obtain the broadest patent estate coverage possible of any genetically targeted addiction related pharmaceutical asset.” About Adial Pharmaceuticals, Inc. Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of therapies for the treatment and prevention of addiction and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company’s ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes identified using the Company’s proprietary companion diagnostic genetic test. ONWARD showed promising results in reducing heavy drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at www.adial.com. If you are interested in exploring partnership opportunities with Adial, we invite you to reach out to us (BD@adialpharma.com) to discuss how our joint efforts can bring about positive change in the millions of patients who are struggling with addiction. Forward-Looking Statements This communication contains certain "forward-looking statements" within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could" are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding the HTR3A, HTR3B, and SLC6A4 receptor sites playing an important role in our precision medicine approach to treating addiction and supporting the expansion of our pipeline, advancing AD04 toward commercialization, obtaining the broadest patent estate coverage possible of any genetically targeted addiction related pharmaceutical asset and the potential of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to pursue our regulatory strategy, our ability to advance ongoing partnering discussions, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2023, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law. Contact:Crescendo Communications, LLCDavid Waldman / Alexandra SchiltTel: 212-671-1020Email: ADIL@crescendo-ir.com

ATLANTA, Nov. 23, 2022 /PRNewswire/ -- UCB (Euronext: UCB), a global biopharmaceutical company, today announced the publication of long-term open-label extension (OLE) study results of FINTEPLA® (fenfluramine) CIV in Epilepsia. Long-term efficacy and safety findings showed that FINTEPLA, when added to a patient's current anti-epileptic treatment regimen for seizures associated with LGS, was effective in reducing the frequency of multiple seizure types and was generally well tolerated during a median treatment duration of 364 days.1 Study participants experienced a sustained reduction in the frequency of motor seizures including those that resulted in a drop or fall like generalized tonic-clonic seizures (GTCS), secondary GTCS, focal to bilateral tonic-clonic, tonic seizures, atonic seizures, and tonic-atonic seizures.1 LGS is a severe childhood-onset developmental and epileptic encephalopathy characterized by drug-resistant seizures with high morbidity3 as well as serious impairment of neurodevelopmental, cognitive, and motor functions.4 LGS has far-reaching effects beyond seizures, including issues with communication, psychiatric symptoms, sleep, behavioral challenges, and mobility.5 LGS affects 30,000 to 50,000 people in the U.S.6 "This long-term safety and efficacy interim analysis of adjunctive FINTEPLA showed that patients with LGS experienced sustained, clinically meaningful reductions in the frequency of seizures associated with a drop, with a particularly robust reduction in the frequency of GTCS, which are associated with sudden unexpected death in epilepsy," said Kelly Knupp, M.D., MSCS, FAES, Associate Professor, Children's Hospital Colorado, and principal investigator of the study. "Given the sustained efficacy and tolerability of FINTEPLA over time, this medication could be an important long-term therapeutic option for patients with LGS, who are highly treatment-resistant, and could be an especially important therapeutic option for LGS patients who experience a high burden of GTCS." Results of the OLE study showed the median percentage change in monthly frequency of seizures associated with a drop from pre-randomized baseline was -28.6% over the entire OLE (P<0.0001) and -50.5% at month 15 (P<0.0001). Nearly one-third of patients (31.1%) experienced a clinically meaningful 50% or greater reduction in the percentage of seizures associated with a drop, including 11.6% of patients who demonstrated a profound 75% or greater reduction. The median percentage change in the frequency of all motor seizures was 45.9% (P=0.0038).1 GTCS and tonic seizures were most responsive to LGS treatment with FINTEPLA.1 Over the entire OLE, the median percentage change in GTCS from pre-randomized baseline was -48.8% (P<0.0001), and, over time, ranged from -56.4% at Month 7-9 (P<0.0001) to -79.1% at Month 13-15 (P<0.0001).1 The median percentage change in tonic seizures was -35.8% over the entire OLE (P<0.0001) and, over time, ranged from -37.1% at Month 4-6 (P<0.0001) to -62.6% at Month 13-15 (P<0.0001).1 Within the study, the authors note the reason these data are compelling is because GTCS are commonly observed in patients with LGS.1 Moreover, GTCS may result in bodily injury.7,8 Sudden unexpected death in epilepsy (SUDEP) is a major concern for people living with LGS, and patients with a history of GTCS have an estimated 10-fold greater risk of SUDEP.9,10 The OLE study also demonstrated that FINTEPLA was generally well tolerated. The most common treatment-emergent adverse events observed in the OLE were decreased appetite, fatigue, nasopharyngitis, and seizure. The cardiovascular safety in this study further corroborates the FINTEPLA safety pro no cases of valvular heart disease or pulmonary arterial hypertension were observed. "This open label extension provides strong evidence that FINTEPLA is effective in reducing multiple seizure types associated with LGS, particularly more severe generalized seizures for up to 15 months," said Brad Chapman, U.S. Head of Epilepsy and Rare Syndromes, UCB. "We are pleased to be able to offer FINTEPLA to those living with and caring for people with LGS to help reduce the impact of this devastating disease and potentially, improve the quality of life for those living with LGS." Additional results of the OLE found that approximately one-third of investigators (37.6%) and caregivers (35.2%) rated their patients as "Much Improved" or "Very Much Improved" on the Clinical Global Impression of Improvement (CGI-I) scale.1 FINTEPLA was approved by the U.S. Food and Drug Administration (FDA) for the treatment of LGS in patients 2 years of age and older in March 2022 and for the treatment of Dravet syndrome (DS) in patients 2 years of age and older in June 2020. UCB acquired Zogenix, Inc. and FINTEPLA in March 2022. Study Design As of October 19, 2020, 247 eligible patients entered the OLE study after the patients completed participation in the multi-center, double-blind, parallel-group Phase 3 clinical trial that enrolled children and adults, age 2 to 35 years, with a confirmed LGS diagnosis who were using stable anti-seizure medication regimens at 65 study sites in North America, Europe, and Australia. In that randomized trial, a total of 263 patients were assigned to receive either FINTEPLA 0.7 mg/kg/day (n=87) or FINTEPLA 0.2 mg/kg/day (n=89) or placebo (n=87). After titration (2-week period), patients were maintained on their randomized dose for 12 additional weeks. A total of 247 eligible patients with LGS who completed that 14-week randomized Phase 3 clinical trial enrolled in the OLE study. Patients were eligible to enroll if they had not experienced any of the following at the end of the Phase 3 clinical trial: clinically meaningful worsening of seizures, clinically significant laboratory findings, or weight loss greater than 15% during the titration and maintenance period that failed to stabilize. The median age of the patients was 14.3 years. All patients were maintained on a stable antiseizure medication regimen of concomitant antiseizure medications during the entire OLE treatment period, and 88.3% received two to four concomitant antiseizure medications. All patients in the OLE were initially started on FINTEPLA 0.2 mg/kg/day. After one month, they were flexibly titrated to effectiveness and tolerability, up to a maximum of 0.7 mg/kg/day, which were assessed at three-month intervals. They were treated with FINTEPLA for a median treatment duration of 364 days. The Phase 3 clinical trial and OLE study were both sponsored by Zogenix, Inc., now part of UCB. The trial is still ongoing. About FINTEPLA® (fenfluramine) C-IV FINTEPLA® (fenfluramine) oral solution is a prescription medication approved in the U.S., Europe, and in Japan, for the treatment of seizures associated with Dravet syndrome in patients two years of age and older. FINTEPLA is also approved in the U.S. for the treatment of seizures associated with Lennox-Gastaut syndrome.2 In the U.S., FINTEPLA is available through a restricted distribution program, called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program. Further information is available at www.FinteplaREMS.com or by telephone at 1-877-964-3649. Please see full Prescribing Information, including Boxed Warning, for additional important information on FINTEPLA. INDICATIONS AND USAGE2 FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older. IMPORTANT SAFETY INFORMATION BOXED WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION There is an association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease and pulmonary arterial hypertension. Echocardiogram assessments are required before, during, and after treatment with FINTEPLA. FINTEPLA is available only through a restricted program called the FINTEPLA REMS. CONTRAINDICATIONS FINTEPLA is contraindicated in patients with hypersensitivity to fenfluramine or any of the excipients in FINTEPLA and with concomitant use, or within 14 days of the administration of monoamine oxidase inhibitors because of an increased risk of serotonin syndrome. WARNINGS AND PRECAUTIONS Valvular Heart Disease and Pulmonary Arterial Hypertension (see Boxed Warning): Because of the association between serotonergic drugs with 5–HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease (VHD) and pulmonary arterial hypertension (PAH), cardiac monitoring via echocardiogram is required prior to starting treatment, during treatment, and after treatment with FINTEPLA concludes. Cardiac monitoring via echocardiogram can aid in early detection of these conditions. In clinical trials for DS and LGS of up to 3 years in duration, no patient receiving FINTEPLA developed VHD or PAH. Monitoring: Prior to starting treatment, patients must undergo an echocardiogram to evaluate for VHD and PAH. Echocardiograms should be repeated every 6 months, and once at 3-6 months post treatment with FINTEPLA. The prescriber must consider the benefits versus the risks of initiating or continuing treatment with FINTEPLA if any of the following signs are observed via echocardiogram: valvular abnormality or new abnormality; VHD indicated by mild or greater aortic regurgitation or moderate or greater mitral regurgitation, with additional characteristics of VHD (eg, valve thickening or restrictive valve motion); PAH indicated by elevated right heart/pulmonary artery pressure (PASP >35mmHg). FINTEPLA REMS Program (see Boxed Warning): FINTEPLA is available only through a restricted distribution program called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribers must be certified by enrolling in the FINTEPLA REMS. Prescribers must counsel patients receiving FINTEPLA about the risk of valvular heart disease and pulmonary arterial hypertension, how to recognize signs and symptoms of valvular heart disease and pulmonary arterial hypertension, the need for baseline (pretreatment) and periodic cardiac monitoring via echocardiogram during FINTEPLA treatment, and cardiac monitoring after FINTEPLA treatment. Patients must enroll in the FINTEPLA REMS and comply with ongoing monitoring requirements. The pharmacy must be certified by enrolling in the FINTEPLA REMS and must only dispense to patients who are authorized to receive FINTEPLA. Wholesalers and distributors must only distribute to certified pharmacies. Further information is available at www.FinteplaREMS.com or by telephone at 1-877-964-3649. Decreased Appetite and Decreased Weight: FINTEPLA can cause decreases in appetite and weight. Decreases in weight appear to be dose related. Approximately half of the patients with LGS and most patients with DS resumed the expected measured increases in weight during the open-label extension studies. Weight should be monitored regularly during treatment with FINTEPLA, and dose modifications should be considered if a decrease in weight is observed. Somnolence, Sedation, and Lethargy: FINTEPLA can cause somnolence, sedation, and lethargy. Other central nervous system (CNS) depressants, including alcohol, could potentiate these effects of FINTEPLA. Prescribers should monitor patients for somnolence and sedation and should advise patients not to drive or operate machinery until they have gained sufficient experience on FINTEPLA to gauge whether it adversely affects their ability to drive or operate machinery. Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including FINTEPLA, increase the risk of suicidal thoughts or behaviors in patients taking these drugs for any indication. Patients treated with an AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviors, or any unusual changes in mood or behavior. Anyone considering prescribing FINTEPLA or any other AED must balance the risk of suicidal thoughts or behaviors with the risks of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behaviors. Should suicidal thoughts and behaviors emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Withdrawal of Antiepileptic Drugs: As with most AEDs, FINTEPLA should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. If withdrawal is needed because of a serious adverse reaction, rapid discontinuation can be considered. Serotonin Syndrome: Serotonin syndrome, a potentially life-threatening condition, may occur with FINTEPLA, particularly during concomitant administration of FINTEPLA with other serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, dietary supplements (eg, St. John's Wort, tryptophan), drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs], which are contraindicated with FINTEPLA), dextromethorphan, lithium, tramadol, and antipsychotics with serotonergic agonist activity. Patients should be monitored for the emergence of signs and symptoms of serotonin syndrome, which include mental status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular signs (eg, hyperreflexia, incoordination), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea). If serotonin syndrome is suspected, treatment with FINTEPLA should be stopped immediately and symptomatic treatment should be started. Increase in Blood Pressure: FINTEPLA can cause an increase in blood pressure. Rare cases of significant elevation in blood pressure, including hypertensive crisis, has been reported in adult patients treated with fenfluramine, including patients without a history of hypertension. In clinical trials for DS and LGS of up to 3 years in duration, no pediatric or adult patient receiving FINTEPLA developed hypertensive crisis. Monitor blood pressure in patients treated with FINTEPLA. Glaucoma: Fenfluramine can cause mydriasis and can precipitate angle closure glaucoma. Consider discontinuing treatment with FINTEPLA in patients with acute decreases in visual acuity or ocular pain. ADVERSE REACTIONS The most common adverse reactions observed in DS studies (incidence at least 10% and greater than placebo) were decreased appetite; somnolence, sedation, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbance; blood pressure increased; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; status epilepticus. The most common adverse reactions observed in the LGS study (incidence at least 10% and greater than placebo) were diarrhea; decreased appetite; fatigue; somnolence; vomiting. DRUG INTERACTIONS Strong CYP1A2, CYP2B6, or CYP3A Inducers: Coadministration with strong CYP1A2, CYP2B6, or CYP3A inducers will decrease fenfluramine plasma concentrations. If coadministration of a strong CYP1A2, CYP2B6, or CYP3A inducer with FINTEPLA is necessary, monitor the patient for reduced efficacy and consider increasing the dosage of FINTEPLA as needed. If a strong CYP1A2, CYP2B6, or CYP3A inducer is discontinued during maintenance treatment with FINTEPLA, consider gradual reduction in the FINTEPLA dosage to the dose administered prior to initiating the inducer. Strong CYP1A2 or CYP2D6 Inhibitors: Coadministration with strong CYP1A2 or CYP2D6 inhibitors will increase fenfluramine plasma concentrations. If FINTEPLA is coadministered with strong CYP1A2 or CYP2D6 inhibitors, the maximum daily dosage of FINTEPLA is 20 mg. If a strong CYP1A2 or CYP2D6 inhibitor is discontinued during maintenance treatment with FINTEPLA, consider gradual increase in the FINTEPLA dosage to the dose recommended without CYP1A2 or CYP2D6 inhibitors. If FINTEPLA is coadministered with stiripentol and a strong CYP1A2 or CYP2D6 inhibitor, the maximum daily dosage of FINTEPLA is 17 mg. USE IN SPECIFIC POPULATIONS Administration to patients with hepatic impairment is not recommended. To report SUSPECTED ADVERSE REACTIONS, contact Zogenix Inc. at 1-866-964-3649 (1-866-Zogenix) or FDA at 1-800-FDA-1088 or . Please see full Prescribing Information, including Boxed Warning, for additional important information on FINTEPLA. About UCB UCB, Brussels, Belgium ( ) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8 600 people in approximately 40 countries, the company generated revenue of € 5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.