Last update 21 Nov 2024

Naltrexone

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryNaltrexone, an opioid antagonist, has been utilized for treating addiction to both drugs and alcohol. VIVITROL, a medication containing naltrexone, is approved for patients with alcohol dependence who can abstain from alcohol before medication initiation. At the initial administration of VIVITROL, patients must not be actively drinking. Following opioid detoxification, VIVITROL can also be utilized to prevent relapse to opioid dependence. It is vital to keep in mind that VIVITROL should be incorporated into a comprehensive management program that includes psychosocial support. Naltrexone works by blocking opioid receptors, specifically the mu/kappa/delta receptors, thus preventing the effects of opioids. Unlike buprenorphine and methadone that activate opioid receptors to suppress cravings, naltrexone binds and blocks opioid receptors, reducing opioid cravings. Moreover, it does not cause withdrawal symptoms upon discontinuation and does not possess abuse and diversion potential.

Drug Type

Small molecule drug

Synonyms

DBR-LDN, Naltrexone implant, naltrexone prodrugs (transdermal/microneedle, opioid dependence/alcoholism), AllTranz/University of Kentucky

+ [10]

Target

Opioid receptors x μ opioid receptor

Mechanism

Opioid receptors antagonists(Opioid receptors antagonists), μ opioid receptor antagonists(Mu opioid receptor antagonists)

Therapeutic Areas

Other DiseasesImmune System DiseasesNervous System Diseases+ [1]

Active Indication

Opium DependenceAlcoholismMethamphetamine abuse+ [9]

Inactive Indication

Acral Lentiginous Malignant MelanomaAlcohol-Related DisordersAmphetamine-Related Disorders+ [24]

Originator Organization

Alkermes, Inc.

Active Organization

Neurelis, Inc.

National Institute of Mental Health

Aardvark Therapeutics, Inc.Startup

+ [6]

Inactive Organization

Opiant Pharmaceuticals, Inc.

National Institute of Diabetes & Digestive & Kidney Diseases

National Cancer Institute

+ [6]

Drug Highest PhaseApproved

First Approval Date

US (13 Apr 2006),

Alcoholism

RegulationOrphan Drug (US), Priority Review (CN)

Structure

Molecular FormulaC20H23NO4

InChIKeyDQCKKXVULJGBQN-XFWGSAIBSA-N

CAS Registry16590-41-3

258

Clinical Trials associated with Naltrexone

NCT06633900 / Not yet recruitingPhase 2/3IIT

Extended-Release Naltrexone as Opioid Overdose Pre-Exposure Prophylaxis (PrEP) in People Using Stimulants Living With or At Risk of HIV

The goal of this clinical trial is to see if an injectable medicine called naltrexone can prevent fentanyl overdose deaths in people who use other drugs (cocaine, methamphetamine). The main questions it aims to answer are:
What are the challenges for implementing naltrexone as an overdose prevention strategy?
Are injections of naltrexone effective for opioid overdose prevention among people who use stimulants?
How often are people who use stimulants and do not intentionally use opioids unintentionally exposed to opioids?
Researchers will compare participants to receive the study medication to the usual care group to see if one group experiences fewer opioid overdose events than the other.
Participants will be randomized to either receive a monthly injection of naltrexone over six months, or receive usual care. Usual care includes harm reduction supplies. Laboratory procedures will include the collection of urine, blood, and hair samples for various safety and outcome measure testing.

Start Date15 Dec 2024

Sponsor / Collaborator

The University of California, San Francisco

[+1]

NCT06622239 / Not yet recruitingPhase 2IIT

A Randomized, Double-Blinded Clinical Trial to Evaluate the Effects of Naltrexone in Improving Nonsuicidal Self-injurious Behavior

The goal of this clinical trial is to learn if naltrexone works to treat nonsuicidal self-injurious behavior in adolescents and adults.

Start Date01 Dec 2024

Sponsor / Collaborator

Seoul National University Hospital

[+1]

CTRI/2024/11/076189 / Not yet recruitingPhase 2IIT

A study of naltrexone and topiramate combination versus naltrexone alone in craving in alcohol dependence - NIL

Start Date06 Nov 2024

Sponsor / Collaborator-

100 Clinical Results associated with Naltrexone

100 Translational Medicine associated with Naltrexone

100 Patents (Medical) associated with Naltrexone

7,501

Literatures (Medical) associated with Naltrexone

01 Jan 2025·Brain, Behavior, and Immunity

Inflammatory pain resolution by mouse serum-derived small extracellular vesicles

Article

Author: Pande, Richa ; Sacan, Ahmet ; Tian, Yuzhen ; DaCunza, Jason T. ; Furdui, Cristina M ; Ajit, Seena K. ; Wickman, Jason R ; Ajit, Seena K ; Wickman, Jason R. ; Luo, Xuan ; Lee, Jingyun ; Kasimoglu, Ezgi E. ; Furdui, Cristina M. ; Reddy, Deepa ; Triana, Vivian ; Pink, Desmond ; Kasimoglu, Ezgi E ; DaCunza, Jason T ; Lin, Zhucheng

Current treatments for chronic pain have limited efficacy and significant side effects, warranting research on alternative strategies for pain management. One approach involves using small extracellular vesicles (sEVs), or exosomes, to transport beneficial biomolecular cargo to aid pain resolution. Exosomes are 30-150 nm sEVs that can be beneficial or harmful depending on their source and cargo composition. We report a comprehensive multi-modal analysis of different aspects of sEV characterization, miRNAs, and protein markers across sEV sources. To investigate the short- and long-term effects of mouse serum-derived sEVs in pain modulation, sEVs from naïve control or spared nerve injury (SNI) model male donor mice were injected intrathecally into naïve male recipient mice. These sEVs transiently increased basal mechanical thresholds, an effect mediated by opioid signaling as this outcome was blocked by naltrexone. Mass spectrometry of sEVs detected endogenous opioid peptide leu-enkephalin. sEVs from naïve female mice have higher levels of leu-enkephalin compared to male, matching the analgesic onset of leu-enkephalin in male recipient mice. In investigating the long-term effect of sEVs, we observed that a single prophylactic intrathecal injection of sEVs two weeks prior to induction of the pain model in recipient mice accelerated recovery from inflammatory pain after complete Freund's adjuvant (CFA) injection. Our exploratory studies examining immune cell populations in spinal cord and dorsal root ganglion using ChipCytometry suggested alterations in immune cell populations 14 days post-CFA. Flow cytometry confirmed increases in CD206⁺ macrophages in the spinal cord in sEV-treated mice. Collectively, these studies demonstrate multiple mechanisms by which sEVs can attenuate pain.

01 Jan 2025·Journal of Substance Use and Addiction Treatment

Relationship of hub and treatment characteristics with client outcomes in the initial Washington State hub and spoke cohort

Article

Author: Lee, Margaret T. ; Lee, Margaret T ; Shields, Morgan C. ; Stewart, Maureen T ; Brolin, Mary F. ; Mazel, Shayna B ; Ritter, Grant ; Wicks, Jennifer J. ; Panas, Lee ; Shields, Morgan C ; Reif, Sharon ; Mazel, Shayna B. ; Daily, Shay M ; Daily, Shay M. ; Brolin, Mary F ; Stewart, Maureen T. ; Wicks, Jennifer J

INTRODUCTIONWashington State's Hub and Spoke (HS) approach aims to improve availability of opioid use disorder (OUD) treatment. Washington initially funded six hubs with expertise in medications for opioid use disorder (MOUD) that built care networks with referral and treatment partners (spokes). We assessed outcomes for the initial HS cohort, considering the role of HS and treatment characteristics.METHODSWe conducted a cohort-based observational study using 2017-2019 Medicaid claims data for 2841 HS participants aged 18-64, excluding those with past-month MOUD, in an intent-to-treat analysis. We describe treatment characteristics (MOUD type, treatment setting, and hub type at the initial HS visit, number of outpatient services in their first HS month), and six-month outcomes (MOUD continuity, emergency department (ED) utilization, hospitalization, and intensive SUD treatment). We used multivariable regressions to assess associations with six-month outcomes, adjusting for client characteristics.RESULTSTwo-thirds (68 %) of participants received buprenorphine, 22 % methadone, 5 % naltrexone, and 5 % outpatient without MOUD for their initial visit. Within six months, 45 % had an ED visit, 14 % any hospitalization, and 18 % entered intensive SUD treatment. Only 24 % remained on MOUD for six months. Compared to buprenorphine, the methadone sample had higher odds of MOUD continuity (aOR = 2.81, 95%CI 2.21-3.55), and the naltrexone sample had lower odds (aOR = 0.36, 95%CI 0.19-0.66). FQHC/public health treatment settings had higher odds of MOUD continuity (aOR = 1.70, 95%CI 1.17-2.47) but hub type was not significant. MOUD continuity increased with 2+ outpatient services for the buprenorphine sample (aOR range 2.55-4.73). Odds of intensive SUD treatment were lower for the methadone sample, compared to buprenorphine (aOR = 0.16, 95%CI 0.11-0.23), all settings compared to SUD settings (aOR range 0.32-0.58), and SUD + MH and medical/hospital hubs compared to SUD only hubs (aOR range 0.28-0.41).CONCLUSIONSMost participants did not attain six-month MOUD continuity, despite the HS approach, with variations by MOUD type and treatment setting. The number of outpatient services in the first month for buprenorphine clients was associated with greater odds of MOUD continuity and reduced odds of intensive SUD treatment. More work is needed to improve MOUD continuity for people with OUD within the HS model.

01 Dec 2024·Journal of Substance Use and Addiction Treatment

An economic analysis of the cost of mobile units for harm reduction, naloxone distribution, and medications for opioid use disorder

Article

Author: Feder, Noah M ; Castry, Mathieu ; Linas, Benjamin P ; Chatterjee, Avik ; Tin, Yjuliana ; Samet, Jeffrey H. ; Barocas, Joshua A ; Feder, Noah M. ; Barocas, Joshua A. ; Samet, Jeffrey H ; Gilbert, Louisa ; Medley, Bethany ; Linas, Benjamin P. ; Rudorf, Maria ; Beers, Donna ; Lewis, Nikki

BACKGROUND & OBJECTIVEMobile substance use treatment units are effective approaches to increase treatment access and reduce barriers to opioid use disorder (OUD) care. However, little is known about the economic costs of maintaining and operating these units. This study aimed to estimate the economic costs of starting and maintaining mobile units providing harm reduction, overdose education and naloxone distribution (OEND), and medication for opioid use disorder (MOUD).METHODSAs part of the HEALing Communities Study, four communities in Massachusetts (Bourne/Sandwich, Brockton, Gloucester, Salem) implemented mobile units offering OEND and MOUD (buprenorphine and naltrexone only); each selected different services tailored to their community. All provided MOUD linkage via telehealth, but only one offered in-person MOUD prescribing on the unit. We retrospectively collected detailed resource utilization data from invoices to estimate the direct economic costs from August 2020 through June 2022. Cost components were categorized into start-up and operating costs. We calculated total economic cost over the study period and the average monthly operating cost.RESULTSImplementing a mobile unit offering OEND and MOUD required a one-time median start-up cost of $59,762 (range: $52,062-$113,671), with 80 % of those costs attributed to the vehicle purchase. The median monthly operating cost was $14,464. The largest cost category for all mobile units was personnel costs. The monthly ongoing costs varied by community settings and services: approximately $5000 for two urban communities offering OEND and MOUD linkage via telehealth (Gloucester, Salem), $28,000 for a rural community (Bourne/Sandwich), and $23,000 for an urban community also providing in-person MOUD prescribing on the unit (Brockton).CONCLUSIONThe economic costs of mobile substance use treatment and harm reduction units are substantial but vary by community settings and services offered. Our results provide valuable community-level economic data to stakeholders and policymakers considering establishing and/or expanding mobile units with OEND and MOUD services. Further exploration of cost-effectiveness and efficiency should be considered across different settings.

255

News (Medical) associated with Naltrexone

15 Nov 2024

·www.globenewswire.com

Scilex Holding Company Announces Presentation of Data 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. , Nov. 15, 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 presentation of data 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. A PDF accompanying this announcement is available at http://ml.globenewswire.com/Resource/Download/f5fbf217-49d5-426d-bae2-028acefb4dd3 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 are 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 acute pain and for which Scilex has recently completed a Phase 2 trial in acute 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. For more information on Scilex Holding Company, refer to www.scilexholding.com About Semnur Pharmaceuticals, Inc. Semnur Pharmaceuticals, Inc. (“Semnur”) is a clinical, late-stage specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. Semnur’s lead program, SP-102 (SEMDEXA™), is the first non-opioid novel gel formulation administered epidurally in development for patients with moderate to severe chronic radicular pain/sciatica. Semnur Pharmaceuticals, Inc. is headquartered in Palo Alto, California. For more information on Semnur Pharmaceuticals, refer to www.semnurpharma.com 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.

Fast TrackDrug ApprovalPhase 3Phase 1Phase 2

13 Nov 2024

·www.drugs.com

Ozempic Could Help Curb Alcoholism

WEDNESDAY, Nov. 13, 2024 -- The blockbuster GLP-1 drug semaglutide ( Ozempic , Wegovy ) could curb drinking for people battling alcohol use disorder , helping them to avoid crises that require hospitalization, new research shows. Numerous studies had already hinted that semaglutide might act on appetite centers in the brain to suppress the urge to drink, just as it does the urge to overeat. Now, researchers in Finland say their nearly nine-year study of almost 228,000 Swedish people with alcohol use disorder who were taking semaglutide had a 36% lower odds of requiring hospitalization. Use of a second drug in the same class of GLP-1 medications, liraglutide ( Victoza ), was linked to a 28% reduction in hospitalizations, the team reported Nov. 13 in the journal JAMA Psychiatry . The study couldn't prove cause and effect, only associations. However, based on these and prior findings, the researchers say that "clinical trials are urgently needed to confirm these findings." The research was led by Dr. Markku Lähteenvuo , of the University of Eastern Finland. Besides the finding that both semaglutide and liraglutide appeared to help keep people with alcohol use disorder out of the hospital, the study also found that semaglutide, in particular, was linked to a decreased risk for suicide. The researchers also noted that the two GLP-1 drugs appeared to outperform standard anti- alcoholism medications, such as naltrexone, disulfiram and acamprostate, in lowering hospitalizations among people with alcohol use disorder, although better studies are needed to confirm that. The Finnish group noted that better treatments for alcohol use disorder are desperately needed, "because existing treatments may not be suitable for all patients." Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

24 Oct 2024

·www.prnewswire.com

Alkermes plc Reports Third Quarter 2024 Financial Results

— Third Quarter Revenues of $378.1 Million — — Net Sales of Proprietary Products Increased Approximately 18% Year-Over-Year — — GAAP Net Income from Continuing Operations of $92.8 Million and Diluted GAAP Earnings per Share from Continuing Operations of $0.56 — — Company Reiterates 2024 Financial Expectations — DUBLIN, Oct. 24, 2024 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today reported financial results for the third quarter of 2024. "Our third quarter financial results reflect strong year-over-year growth of our portfolio of proprietary commercial products and position us well to meet our strategic, operational and financial priorities for the year. Looking ahead, we believe growing our proprietary commercial products and advancing our pipeline, particularly ALKS 2680, our novel, investigational, orexin 2 receptor agonist, and additional orexin development candidates, will serve as the key drivers of shareholder value. We plan to manage the business to deliver significant profitability and cash flow while investing in these strategic initiatives," said Richard Pops, Chief Executive Officer of Alkermes. "2025 has the potential to be a transformational year for Alkermes as we expect to complete the ongoing phase 2 studies in narcolepsy type 1 and narcolepsy type 2, and prepare for potential registrational studies for ALKS 2680. With the potential to transform the treatment of hypersomnolence disorders, and with broad potential applicability across other symptomatic domains, orexin 2 receptor agonists represent one of the most exciting new therapeutic categories in development and we believe a significant opportunity for Alkermes and our shareholders." Key Financial Highlights *As a result of the successful resolution of the arbitration with Janssen Pharmaceutica N.V., the nine months ended September 30, 2023 included approximately $195.4 million of back royalties (and related interest) related to U.S. net sales of long-acting INVEGA® products that would ordinarily have been recognized in prior periods. Revenue Highlights LYBALVI Revenues for the quarter were $74.7 million. Revenues and total prescriptions for the quarter grew 47% and 37%, respectively, compared to the third quarter of 2023. ARISTADAi Revenues for the quarter were $84.7 million. VIVITROL Revenues for the quarter were $113.7 million. Revenues for the quarter grew 14% compared to the third quarter of 2023, driven by the alcohol dependence indication. Manufacturing & Royalty Revenues Royalty revenues from INVEGA SUSTENNA®/XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® for the quarter were $58.4 million. VUMERITY® manufacturing and royalty revenues for the quarter were $32.6 million. Key Operating Expenses Please see Note 1 below for details regarding discontinued operations. Balance Sheet At Sept. 30, 2024, the company recorded cash, cash equivalents and total investments of $927.8 million, compared to $962.5 million at June 30, 2024. The company's total debt outstanding as of Sept. 30, 2024 was $288.8 million. Share Repurchase Program During the third quarter of 2024, the company repurchased approximately 4.4 million of the company's ordinary shares under the share repurchase program authorized in February 2024, at a total purchase price of $115.6 million. As of Sept. 30, 2024, the company had $200 million (exclusive of any fees, commissions or other related expenses) remaining under the program. Financial Expectations for 2024 Alkermes reiterates its financial expectations for 2024, as set forth in its press release dated Feb. 15, 2024. Recent Events In October 2024, the company hosted an investor event to review its portfolio of orexin 2 receptor agonists and development strategy. The company presented data from its ALKS 2680 phase 1b study in patients with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), and discussed the study design for its ongoing phase 2 studies in NT1 and NT2. The company also announced its plans to initiate a phase 2 study in patients with IH in 2025. In September 2024, the company presented positive clinical data from its phase 1b study of ALKS 2680 in patients with NT2 and IH at the European Sleep Research Society's 27th Congress, Sleep Europe 2024. In August 2024, the company announced the initiation of its Vibrance-2 phase 2 study of ALKS 2680 in patients with NT2. In August 2024, the company published its latest Corporate Responsibility Report, which details how the company integrates environmental, social and governance considerations into its business. A copy of the report is available on the Responsibility section of Alkermes' website. Notes and Explanations 1. The company determined that upon the separation of its oncology business, completed on Nov. 15, 2023, the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board Accounting Standards Codification 205, Discontinued Operations. Accordingly, the accompanying selected financial information has been updated to present the results of the oncology business as discontinued operations for the three and nine months ended Sept. 30, 2023. Conference Call Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Thursday, Oct. 24, 2024, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes' website at . The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes' website. About Alkermes plc Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy and idiopathic hypersomnia. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes' website at . Non-GAAP Financial Measures This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the U.S. (GAAP), including non-GAAP net income and EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. Non-GAAP net income adjusts for certain one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; change in the fair value of contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items. EBITDA represents earnings before interest, tax, depreciation and amortization; earnings include share-based compensation expense. The company's management and board of directors utilize these non-GAAP financial measures to evaluate the company's performance. The company provides these non-GAAP financial measures of the company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income and EBITDA are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income and EBITDA should not be considered measures of the company's liquidity. A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. Note Regarding Forward-Looking Statements Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company’s expectations concerning its future financial and operating performance, business plans or prospects, including drivers of shareholder value and profitability; and the company’s expectations regarding development plans, activities and timelines for, and the potential therapeutic and commercial value of, ALKS 2680 and the company’s other orexin portfolio candidates. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether the company is able to achieve its financial expectations, including those related to profitability; the unfavorable outcome of arbitration or litigation, including so-called “Paragraph IV” litigation and other patent litigation which may lead to competition from generic drug manufacturers, or other disputes related to the company’s products or products using the company’s proprietary technologies; clinical development activities may not be completed on time or at all; the results of the company’s development activities may not be positive, or predictive of final results from such activities, results of future development activities or real-world results; the U.S. Food and Drug Administration (FDA) or regulatory authorities outside the U.S. may make adverse decisions regarding the company’s products; the company and its licensees may not be able to continue to successfully commercialize their products or support revenue growth from such products; there may be a reduction in payment rate or reimbursement for the company’s products or an increase in the company’s financial obligations to government payers; the company’s products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended Dec. 31, 2023 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at . Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release. VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA®, ARISTADA INITIO® and LYBALVI® are registered trademarks of Alkermes Pharma Ireland Limited, used by Alkermes, Inc. under license; BYANNLI®, INVEGA®, INVEGA HAFYERA®, INVEGA SUSTENNA®, INVEGA TRINZA®, TREVICTA® and XEPLION® are registered trademarks of Johnson & Johnson or its affiliated companies; and VUMERITY® is a registered trademark of Biogen MA Inc., used by Alkermes under license. i The term "ARISTADA" as used in this press release refers to ARISTADA and ARISTADA INITIO®, unless the context indicates otherwise. SOURCE Alkermes plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial StatementPhase 1Phase 2Clinical Result

100 Deals associated with Naltrexone

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Opium Dependence	US	Alkermes, Inc.	12 Oct 2010
Alcoholism	US	Alkermes, Inc.	13 Apr 2006

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Unspecified drug dependence	NDA/BLA	-	Alkermes, Inc.	01 Aug 2004
Alcoholism	NDA/BLA	US	National Institute on Drug Abuse	01 Jan 1998
Alcoholism	Phase 2	US	National Institute on Drug Abuse	01 Jan 1998
Cocaine-Related Disorders	Phase 2	US	National Institute on Drug Abuse	01 Jan 1998
opioid dependence methadone	Phase 1	RU	Alkermes, Inc.	01 Jun 2008
Alcohol-Related Disorders	Phase 1	US	National Institute on Alcohol Abuse & Alcoholism	01 Apr 2006
Unspecified drug dependence	Phase 1	-	Alkermes, Inc.	01 Aug 2004
Gambling	Phase 1	US	National Institute of Mental Health	01 Dec 2002
Tobacco Use Disorder	Phase 1	US	National Institute on Drug Abuse	01 Nov 2000
Stimulant dependence	Preclinical	IS	National Institute on Drug Abuse	01 May 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01587196 (fMRI CURE, CTgov)	Phase 2	-	72	Vivitrol	zbksvwlndl(xhrnlpepfr) = uonfayhlmo hyofhtrrru (rdhfjzbszz, fsxomyuoao - dcuvwcfxdg) View more	-	15 Oct 2024
NCT04547985 (CTgov)	Phase 4	-	9	Placebo (Placebo)	fbhszvipfh(qnmahlhssv) = rkosrtubqx bekgusacrt (didwfouarc, ymjmllrqyx - caermtvpdh) View more	-	28 Aug 2024
				Naltrexone HCl 50 MG Oral Tablet (Naltrexone)	fbhszvipfh(qnmahlhssv) = petbtnftzh bekgusacrt (didwfouarc, arnmanfxfp - ltyfrjeepi) View more
NCT04854551 (CTgov)	Phase 1/2	Alcoholism	13	Naltrexone (Naltrexone)	llolawxowl(nvpsmfitpb) = okbxzwfmwj oxfcwkqovp (fdsbdaeisv, fouezbuodg - xclspcjyaj) View more	-	28 Nov 2023
				Placebo (Placebo)	llolawxowl(nvpsmfitpb) = wmkeziatja oxfcwkqovp (fdsbdaeisv, gtwmmcssqs - pbokrnpkqz) View more
ESPE2023	Not Applicable	Craniopharyngioma	-	Intranasal oxytocin	(cttcynivjk) = The patient was treated with intranasal oxytocin for more than 3 years with no side-effects jzkgfkuvav (jqihlenias )	-	21 Sep 2023
				Naltrexone
NCT04249882 (CTgov)	Phase 2	Alcohol Use Disorder	53	Placebo (Placebo)	njqrrcgkls(bhlfmyxuut) = nibbkzuzwa zudhkecljb (ewcbkydboe, iunqhpxwup - jxewindbuv) View more	-	14 Sep 2023
				Varenicline (Varenicline)	njqrrcgkls(bhlfmyxuut) = dkofdcmiuc zudhkecljb (ewcbkydboe, ruyxxcvigf - bqxbddpqyl) View more
NCT04935931 (EDIT-N2, CTgov)	Early Phase 1	Binge-Eating Disorder	13	Naltrexone	irsngrxozi(yeyaockkmd) = ecxsxmwbum cfbbygdpgw (gxtahwvaiw, boerqhsoly - oyftrskdeb) View more	-	21 Aug 2023
NCT04756128 (COLTREXONE, CTgov)	Phase 2	COVID-19	142	Colchicine 0.6 mg (Colchicine-Only Arm)	dlkdrimuyg(eqdijdhclf) = cxwxuhkrqu ktrbaajrwe (phbwgjwuzv, vkvmgfcodp - qyzrkwsmco) View more	-	25 Jul 2023
				Colchicine 0.6 mg+Naltrexone (Colchicine and Naltrexone ("Combined") Arm)	dlkdrimuyg(eqdijdhclf) = phwxxadzwx ktrbaajrwe (phbwgjwuzv, pshglqiyfo - felfvrfpbq) View more
NCT04716881 (CTgov)	Phase 1	Opioid-Related Disorders	9	Naltrexone 380 MG	jktnpgzfon(yhdoswubod) = sjqqzqmhyb pvhshmbftv (ixasnteoki, aclshfaupu - fqrusojoyf) View more	-	09 Jun 2023
NCT03852628 (CTgov)	Phase 2	Alcoholism \| Stress Disorders, Post-Traumatic	69	2mg Buprenex+380mg Vivitrol (2mg Buprenex and 380mg Vivitrol)	cqsupdooxg(tcqfmfmfob) = kcksiemggi vudyltvytd (ouwehnoinw, gcqebttbwv - habusxofug) View more	-	07 Jun 2023
				Placebo (SL pill qd, IM injection q4weeks) (Placebo)	cqsupdooxg(tcqfmfmfob) = krygckmdqn vudyltvytd (ouwehnoinw, ylmnvjhdii - jgiphjewzi) View more
AAD2023	Not Applicable	Pseudopelade	46	Low-dose oral naltrexone	(onchvqrlmt) = Side effects were reported by 21.7% of patients and included insomnia, vivid dreams, and gastrointestinal upset. vglcswavdy (hwuoddtgtf )	-	17 Mar 2023

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