A Phase II Multi-Center Safety Study Examining the Use of the O'Neil Long Acting Naltrexone Implant (OLANI) in Opioid Dependent Persons Receiving Repeat Dosing

This study will examine the safety and efficacy of the O'Neil Long Acting Naltrexone Implant (OLANI) in persons with opioid dependency who are seeking relapse-prevention treatment. All participants will be treated in an open label manner. No randomization will occur. The OLANI is a long-acting biodegradable form of naltrexone which is implanted in the abdominal region. It is hypothesized that the OLANI will produce blood levels sufficient to block the effects of opioids for an extended period allowing patients to engage in psychosocial treatment and recovery over the long term. After the initial set of implants, participants will be offered a second set of implants after 13-24 weeks.

Start Date15 Mar 2025

Sponsor / Collaborator

Go Medical Industries Pty Ltd.

[+5]

NCT05363514 / Not yet recruitingPhase 4

A Pilot Study of Low Dose Naltrexone Use in Patients With Postural Orthostatic Tachycardia Syndrome

Many patients with Postural Orthostatic Tachycardia Syndrome (POTS) experience debilitating fatigue and this significantly impacts their daily lives. Unfortunately, there are no treatments to help POTS patients with their fatigue. One medication, called low dose naltrexone (LDN), has been tested as a treatment for fatigue in other medical conditions. In this other research, LDN helped patients feel less fatigue. Other research studies have shown that LDN can help reduce markers of inflammation called cytokines. Reducing these cytokines could help reduce symptoms as well. There have been no research studies testing LDN in POTS to date. We are planning to do a research study to test LDN as a treatment to see if it helps POTS patients feel less fatigue.

Start Date01 Jan 2025

Sponsor / Collaborator

University of Calgary

NCT06306157 / Enrolling by invitationPhase 4IIT

Low Dose Naltrexone (LDN) Therapy for Complex Regional Pain Syndrome (CRPS): a Feasibility Study

Complex Regional Pain Syndrome (CRPS) is a rare and often debilitating chronic pain condition whereby individuals may experience extreme sensitivity, discoloration, and swelling of the affected area -- along with numerous other painful symptoms. There are currently a limited number of treatment options available to those suffering with the condition, with various treatments including nerve blocks, neuropathic medications, and desensitization physical therapy modules. There is budding interesting in the role naltrexone, an opiate antagonist, may play in the pain management of CRPS when prescribed in very low doses. This study aims to collect preliminary data on pain scores, symptom severity, and side-effects in patients with Complex Regional Pain Syndrome randomized to receive low dose naltrexone or placebo capsules. Enrollment of 40 patients total will occur over two years from study start to study end. Each patient will be randomized to receive placebo capsules or active low dose naltrexone capsules, with both the patient and treating clinician blind to the randomization. Each patient will be actively enrolled in the study for six months and will take the medication daily at the instructed dose for the respective duration of time. Following the initial visit and study enrollment, the investigators are asking each patient to return for three (3) in-person follow-up office visits. These office visits will occur 1 month after the patient starts the medication, 3 months afterwards, and 6 months afterwards. The final 6-month office visit will mark the conclusion of the patient's active participation in the study.

Start Date01 Oct 2024

Sponsor / Collaborator

Hospital for Special Surgery

100 Clinical Results associated with Naltrexone Hydrochloride

100 Translational Medicine associated with Naltrexone Hydrochloride

100 Patents (Medical) associated with Naltrexone Hydrochloride

686

Literatures (Medical) associated with Naltrexone Hydrochloride

01 Nov 2024·ADDICTION

Comparative effectiveness of extended‐release naltrexone and sublingual buprenorphine for treatment of opioid use disorder among Medicaid patients

Article

Author: Rudolph, Kara E. ; Ross, Rachael K. ; Krawczyk, Noa ; Stuart, Elizabeth A. ; Shulman, Matisyahu ; Nunes, Edward V. ; Olfson, Mark

Abstract:

Background and aims:

Extended‐release naltrexone (XR‐NTX) and sublingual buprenorphine (SL‐BUP) are both approved for opioid use disorder (OUD) treatment in any medical setting. We aimed to compare the real‐world effectiveness of XR‐NTX and SL‐BUP.

Design and setting:

This was an observational active comparator, new user cohort study of Medicaid claims records for patients in New Jersey and California, USA, 2016–19.

Participants/cases:

The participants were adult Medicaid patients aged 18–64 years who initiated XR‐NTX or SL‐BUP for maintenance treatment of OUD and did not use medications for OUD in the 90 days before initiation. Our cohort included 1755 XR‐NTX and 9886 SL‐BUP patients.

Measurements:

We examined two outcomes up to 180 days after medication initiation: (1) composite of medication discontinuation and death and (2) composite of overdose and death.

Findings:

In adjusted analyses, treatment with XR‐NTX was more likely to result in discontinuation or death by the end of follow‐up than treatment with SL‐BUP: cumulative risk 75.9% [95% confidence interval (CI) = 73.9%, 77.9%] versus 62.2% (95% CI = 61.2%, 63.2%), respectively (risk difference = 13.7 percentage points, 95% CI = 11.4, 16.0). There was minimal difference in the cumulative risk of overdose or death by the end of follow‐up: XR‐NTX 3.9% (95% CI = 3.0%, 4.8%) versus SL‐BUP 3.3% (95% CI = 2.9%, 3.7%); risk difference = 0.5 percentage points, 95% CI = –0.4, 1.5. Results were consistent across sensitivity analyses.

Conclusions:

Medicaid patients in California and New Jersey, USA, receiving treatment for opioid use disorder stayed in treatment longer on sublingual buprenorphine than on extended‐release naltrexone, but the risk of overdose was similar. Most patients in this study discontinued medication within 6 months, regardless of which medication was initiated.

01 Oct 2024·European journal of dentistry

The Potential Role of Reactive Oxygen Species Produced by Low-Density Neutrophils in Periodontitis

Article

Author: Al Hussaini, Ali Hussien Abass ; Mousa, Ali Omran ; Hussein, Hashim Mueen

Abstract:

Objective Neutrophils own an arsenal of dischargeable chemicals that enable them to handle bacterial challenges, manipulating innate immune response and actual participation in acquired immunity. The reactive oxygen species (ROS) are one of the most important chemicals that neutrophils discharge to eradicate pathogens. Despite their beneficial role, the ROS were strongly correlated to periodontal tissue destruction. Lowdensity neutrophils (LDN) have been recognized for producing enhanced quantities of ROS. However, the potential role of ROS produced by LDN in periodontitis is unknown. The aim of the study was to investigate the impact of ROS produced by LDN in periodontal diseases. Materials and Methods Venous blood and periodontal parameters were obtained from 100 systemically healthy subjects divided into 40 participants with healthy periodontium in the control group and 60 with unstable periodontitis in the study group. Flow cytometry was used to measure the production of ROS by LDN in both groups. Statistical Analysis The data were analyzed for normal distribution using the Shapiro-Wilk test at p < 0.05, Spearman's correlations, and Mann-Whitney U test. Statistical analysis was performed in SPSS v25. Results No difference between the groups had been obtained in ROS production by LDN. However, a significant positive correlation existed between ROS and clinical attachment loss in periodontitis. Conclusion LDN exhibits the same ROS generation capacity in the control and periodontitis groups.

01 Oct 2024·Korean Journal of Pain

Efficacy and safety of low-dose naltrexone for the management of fibromyalgia: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis

Article

Author: Hariyanto, Timotius Ivan ; Yanto, Theo Audi ; Vatvani, Akhil Deepak ; Patel, Pratik

Background:

Fibromyalgia is characterized by the presence of chronic widespread pain that may impair patient's quality of life. Currently, the use of naltrexone as a therapeutic agent for fibromyalgia is not supported by enough evidence, especially from randomized controlled trials (RCTs). This study aims to analyze the efficacy and safety of low-dose naltrexone (LDN) for the management of fibromyalgia.

Methods:

A comprehensive search was conducted on the Scopus, Medline, ClinicalTrials.gov, and Cochrane Library databases up until May 20th, 2024. This review incorporates RCTs that examine the comparison between LDN and placebo in fibromyalgia patients. We employed random-effect models to analyze the odds ratio and mean difference (MD) for presentation of the outcomes.

Results:

A total of 4 RCTs with 222 fibromyalgia patients were incorporated. The results of our meta-analysis showed a significant reduction in pain scores (MD: -0.86, 95% confidence interval [CI]: -1.20, -0.51, P < 0.001, I² = 33%) and higher increment in pressure pain threshold (MD: 0.17, 95% CI: 0.08, 0.25, P < 0.001, I² = 0%) among fibromyalgia patients who received LDN than those who only received a placebo. The fibromyalgia impact questionnaire revised and pain catastrophizing scale did not differ significantly between the two groups. LDN was also associated with higher incidence of vivid dreams and nausea, but showed no significant difference with the placebo in terms of serious adverse events, headache, diarrhea, and dizziness.

Conclusions:

This study suggests the efficacy of LDN in mitigating pain symptoms for fibromyalgia patients with a relatively good safety profile.

News (Medical) associated with Naltrexone Hydrochloride

12 Sep 2024

·www.globenewswire.com

Scilex Holding Company Announces It Has Received the Drug Distributor Accreditation from the National Association of Boards of Pharmacy® (NABP®)

PALO ALTO, Calif., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that it has received the Drug Distributor Accreditation from the National Association of Boards of Pharmacy® (NABP®). Scilex has satisfied all the drug distributor criteria set in place by the NABP. The NABP® is a 501(c)(3) nonprofit organization founded in 1904. Working with their members – the state boards of pharmacy – they help support patient and prescription drug safety, through examinations that assess pharmacist competency, pharmacist licensure transfer and verification services, and various pharmacy accreditation programs. For more information on Scilex Holding Company, refer to www.scilexholding.com For more information on Semnur Pharmaceuticals, refer to www.semnurpharma.com For more information on Scilex Holding Company Sustainability Report, refer to www.scilexholding.com/investors/sustainability For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com. For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com. For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. https://www.facebook.com/scilex.pharm https://www.linkedin.com/company/scilex-holding-company/ info@scilexholding.com About Scilex Holding Company Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA™” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain and for which Scilex has recently completed a Phase 2 trial in low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia, for which Phase 1 trials were completed in the second quarter of 2022. Scilex Holding Company is headquartered in Palo Alto, California. Forward-Looking Statements This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Scilex’s long-term objectives and commercialization plans, future opportunities for Scilex, Scilex’s future business strategies and Scilex’s current and prospective product candidates. Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks associated with the unpredictability of trading markets; general economic, political and business conditions; the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to Scilex Holding Company to use the registered trademark. ELYXYB® is a registered trademark owned by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2024 Scilex Holding Company All Rights Reserved.

Fast TrackDrug ApprovalPhase 3Phase 2License out/in

09 Sep 2024

·www.globenewswire.com

Scilex Holding Company to Present at the 26th Annual H.C. Wainwright Global Investment Conference

PALO ALTO, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that Jaisim Shah, Chief Executive Officer and President of Scilex will present at the 26th Annual H.C. Wainwright Global Investment Conference taking place September 9-11, 2024 in New York City. Details on the presentation: H.C. Wainwright 26th Annual Global Investment Conference Location: Lotte NY Palace Hotel, New York CityDate: September 11, 2024Time: 8-8:30am ET For more information on Scilex Holding Company, refer to www.scilexholding.com For more information on Scilex Holding Company Sustainability Report, refer to www.scilexholding.com/investors/sustainability For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com. For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com. For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. https://www.facebook.com/scilex.pharm https://www.linkedin.com/company/scilex-holding-company/ info@scilexholding.com About Scilex Holding Company Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXATM” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain and for which Scilex has recently completed a Phase 2 trial in low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia, for which Phase 1 trials were completed in the second quarter of 2022. Scilex Holding Company is headquartered in Palo Alto, California. Forward-Looking Statements This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Scilex’s long-term objectives and commercialization plans, future opportunities for Scilex, Scilex’s future business strategies and Scilex’s current and prospective product candidates. Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks associated with the unpredictability of trading markets; general economic, political and business conditions; the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to Scilex Holding Company to use the registered trademark. ELYXYB® is a registered trademark owned by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2024 Scilex Holding Company All Rights Reserved.

Phase 1Fast TrackPhase 3Drug ApprovalLicense out/in

05 Sep 2024

·www.globenewswire.com

Scilex Holding Company Announces Acceptance of Presentation at the 2024 American College of Rheumatology Convergence Conference to be held at the Walter E. Washington Convention Center in Washington, D.C. on November 14 – 19, 2024

PALO ALTO, Calif., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced the acceptance of a presentation at the 2024 American College of Rheumatology Convergence conference to be held at the Walter E. Washington Convention Center in Washington, D.C. on November 14 – 19, 2024. Title: Prophylaxis of Gout Flares in Patients with Renal Impairment: Dosing Adjustments with Colchicine Oral Solution Informed by a Pharmacokinetic Model Authors: Jaymin Shah, PhD, FCP; Elaine K. Chan, PharmD; Dmitri Lissin, MD Presentation: Saturday, November 16, 2024, at 10:30 AM ET - 12:30 PM ET GLOPERBA® (colchicine oral solution) is the first and only liquid formulation of colchicine that offers precision dosing for at risk gout patients.Scilex recently received FDA approval for an updated GLOPERBA® label, which reflects dosing adjustments in various clinical situations. Unlike other colchicine formulations, GLOPERBA® allows reduction of daily dose in patients with severe renal impairment (0.3 mg/day).Data to be presented summarizes pharmacokinetic model derived dosing for at-risk moderate and severe chronic kidney disease patients who require lower precision dosing, not offered by other colchicine formulations of tablets and capsules currently available on the market. For more information on Scilex Holding Company, refer to www.scilexholding.com For more information on Scilex Holding Company Sustainability Report, refer to www.scilexholding.com/investors/sustainability For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com. For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com. For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. https://www.facebook.com/scilex.pharm https://www.linkedin.com/company/scilex-holding-company/ info@scilexholding.com About Scilex Holding Company Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXATM” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain and for which Scilex has recently completed a Phase 2 trial in low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia, for which Phase 1 trials were completed in the second quarter of 2022. Scilex Holding Company is headquartered in Palo Alto, California. Forward-Looking Statements This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Scilex’s expectations for Gloperba to be the first liquid colchicine formulation allowing providers to prescribe precision dosing and reducing daily dose in patients with severe renal impairment. Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks associated with the unpredictability of trading markets; general economic, political and business conditions; the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to Scilex Holding Company to use the registered trademark. ELYXYB® is a registered trademark owned by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2024 Scilex Holding Company All Rights Reserved.

Phase 1Fast TrackDrug ApprovalPhase 3License out/in

100 Deals associated with Naltrexone Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D02095	Naltrexone Hydrochloride	N07BB04	DB00704

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Opium Dependence	CN	Shenzhen Sciencare Medical Industries Co., Ltd.	25 Jun 2024
Alcoholism	US	Teva Women's Health, Inc.	20 Nov 1984
Opioid-Related Disorders	US	Teva Women's Health, Inc.	20 Nov 1984

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Alcohol Use Disorder	Phase 2	CN	Shenzhen Sciencare Medical Industries Co., Ltd.	03 Apr 2023
Crohn Disease	Phase 2	US	Hershey Medical Center	01 Sep 2006
Inflammation	Phase 2	US	Hershey Medical Center	01 Sep 2006
COVID-19	Phase 1	US	Statera Biopharma, Inc.	05 Dec 2021
Inflammatory Bowel Diseases	Preclinical	CN	Shenzhen Sciencare Medical Industries Co., Ltd.	27 Sep 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


P6-12.008 (AAN2024)	Not Applicable	-	42	Low-dose Naltrexone 4.5mg	vphedrolau(iyteyrejwk) = lkeekpoaog anjpbroshp (soajzqqbqq )	Positive	09 Apr 2024
NCT03447743 (CTgov)	Early Phase 1	Opioid abuse \| Opium Dependence	9	XR-NTX community location	xnkgmjhwja(tvuddqomhu) = sbtydguypy wppgaxgijc (eadjummfwl, kavxvxzbhj - jceilpttlz) View more	-	27 Mar 2023
AAD2023	Not Applicable	Pseudopelade	46	Low-dose oral naltrexone	qdssxtdhob(daieqrfhbz) = Side effects were reported by 21.7% of patients and included insomnia, vivid dreams, and gastrointestinal upset. yrwnfhwusy (lzsrlummrj )	-	17 Mar 2023
NCT04052139 (UH3, CTgov)	Phase 2	Alcohol Use Disorder \| Inflammation \| HIV Infections ... View more	45	Low-dose naltrexone (Low-dose Naltrexone)	wsxgqnxdmx(uslvihdrpy) = jundoirluj vezbyshsvu (trwuvpomgj, wsmtpzxtcj - akqzpxnqbg) View more	-	10 Nov 2022
NCT04052139 (UH3, CTgov)	Phase 2		45	Gabapentin (Gabapentin)	wsxgqnxdmx(uslvihdrpy) = njemfjdzpy vezbyshsvu (trwuvpomgj, lahvjrswyn - kmxvmfixon) View more	-	10 Nov 2022
Pubmed	Not Applicable	Alcohol Use Disorder	-	Extended-Release Naltrexone and Case Management	wcmoiwuboa(uifmpyumpf) = xqqlmxviix grnejanhcv (uosrvgbtel ) View more	-	31 Oct 2022
NCT03810495 (CTgov)	Phase 1	Opioid abuse	20	naltrexone implant	jxravmdmni(sjihucdznr) = fuaiftljsn xvcgdjqzaf (dwxblqtyng, rhjiuxyvzi - jwnhwgbows) View more	-	01 Aug 2022
NCT02543944 (GBN, CTgov)	Phase 2/3	Unspecified drug dependence	117	Naltrexone (depot)+Buprenorphine+Clonidine+Gabapentin+Naltrexone (oral) (Gabapentin)	hoozwndkrv(irsshtlgpx) = ydosbhbicx uobgjuiata (nxqcevecyl, ghzcohzwkq - xhpsqwogta) View more	-	28 Jul 2022
NCT02543944 (GBN, CTgov)	Phase 2/3	Unspecified drug dependence	117	Placebo+Naltrexone (depot)+Buprenorphine+Clonidine+Naltrexone (oral) (Placebo)	hoozwndkrv(irsshtlgpx) = kmxxnapwvc uobgjuiata (nxqcevecyl, rxxjgnqolw - hwjxvwqulz) View more	-	28 Jul 2022
NCT04409041 (CTgov)	Phase 2	Lichen Planus Follicularis \| Frontal Fibrosing Alopecia	43	Low-Dose Naltrexone	nhtbcpvbjr(dmryipqobg) = vkyebeshsz wqhtkxewgd (hdaoytknhi, hqwvhqfsfp - wxyuacarap) View more	-	30 Dec 2021
NCT01843023 (CTgov)	Phase 4	Opioid abuse \| Unspecified drug dependence	288	Psychosocial Treatment+Extended Release Naltrexone (Extended Release Naltrexone)	fknhiumvri(kjncpatgev) = hyogybewap dpugyrehjn (caphvvvsrd, bhjxwinmgg - jabuqdpeda) View more	-	10 Nov 2021
NCT01843023 (CTgov)	Phase 4	Opioid abuse \| Unspecified drug dependence	288	Psychosocial Treatment+Buprenorphine (Treatment as Usual)	fknhiumvri(kjncpatgev) = sehptmnyng dpugyrehjn (caphvvvsrd, rddwjpskfm - iojfiggela) View more	-	10 Nov 2021
NCT01402492 (CURB, CTgov)	Phase 2/3	Cocaine-Related Disorders	302	Naltrexone+Buprenorphine (BUP4+XR-NTX)	lbzkbombcr(zjknfysakf) = dlraayrcgf znabfvegpu (zgzwqendok, movukokslc - erusvmrzze) View more	-	29 Oct 2021
NCT01402492 (CURB, CTgov)	Phase 2/3	Cocaine-Related Disorders	302	Naltrexone+Buprenorphine (BUP16+XR-NTX)	lbzkbombcr(zjknfysakf) = aihmjopyxr znabfvegpu (zgzwqendok, wvnldelhht - qjekdhyytb) View more	-	29 Oct 2021

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