MedPath

Nalmefene

Generic Name
Nalmefene
Brand Names
Opvee, Revex, Selincro
Drug Type
Small Molecule
Chemical Formula
C21H25NO3
CAS Number
55096-26-9
Unique Ingredient Identifier
TOV02TDP9I
Background

Nalmefene, a 6-methylene analogue of naltrexone, is an opioid receptor antagonist. It acts as an antagonist at the mu (μ)-opioid and delta (δ)-opioid receptors and a partial agonist at the kappa (κ)-opioid receptor.

In Europe, nalmefene oral tablets are used to reduce alcohol consumption in adults with alcohol dependence. Nalmefene was approved in the United States in 1995 as an antidote for opioid overdose. Nalmefene injection is used to manage known or suspected opioid overdose. It is used for complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. The nasal spray formulation of nalmefene was approved by the FDA in May 2023.

Indication

Nalmefene oral tablet is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL), without physical withdrawal symptoms and who do not require immediate detoxification. Nalmefene should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption. Nalmefene should be initiated only in patients who continue to have a high DRL two weeks after the initial assessment.

Nalmefene injection and nasal spray are indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. They are also indicated in the management of known or suspected opioid overdose. Nalmefene injection can be used for postoperative opioid overdose reversal.

Associated Conditions
Alcohol Dependency, Opioid Overdose
Clinical Trials
Related News

FDA Clears Expedited Pathway for Tharimmune's TH104 Opioid Defense Drug Without Additional Clinical Trials

• Tharimmune received positive FDA feedback allowing a 505(b)(2) NDA submission for TH104 as prophylaxis against ultrapotent opioid exposure, with no additional clinical trials required. • The buccal film formulation of nalmefene (TH104) leverages existing safety and efficacy data, enabling an "in silico" submission using pharmacokinetic modeling to predict drug performance. • Beyond its original development for chronic pruritus in primary biliary cholangitis, TH104 now targets protection for military personnel and first responders entering areas contaminated with high-potency opioids.

Tharimmune Reports Breakthrough in Oral Delivery of TNF-α Inhibitor for Inflammatory Diseases

• Tharimmune's novel oral antibody TH023 demonstrated successful delivery of infliximab in preclinical studies, achieving serum concentrations higher than required for therapeutic efficacy in standard injection treatments. • The proprietary enzyme stabilization platform enables both local intestinal tissue delivery and systemic circulation, making it potentially effective for inflammatory bowel disease and other systemic inflammatory conditions. • The company plans to advance TH023 to first-in-human clinical trials within 12 months, targeting a portion of the global infliximab market that generated $6.3 billion in 2022 and could reach $9 billion within a decade.

FDA Approves Opvee, First Intranasal Nalmefene Therapy for Opioid Overdose

The FDA has granted approval for Opvee, the first intranasal nalmefene therapy for emergency treatment of opioid overdose in patients 12 and older. Developed by Opiant Pharma and now owned by Indivior, the drug offers a longer-acting alternative to existing naloxone treatments amid the ongoing opioid crisis that claimed over 103,000 lives in the past year.

Tharimmune's TH104 Advances to Phase 2 for Pruritus in Primary Biliary Cholangitis

• Tharimmune plans to initiate a Phase 2 clinical trial in 2025 to evaluate TH104 for moderate-to-severe pruritus associated with primary biliary cholangitis (PBC). • The Phase 2 trial will be a multicenter, randomized, double-blind, placebo-controlled study enrolling approximately 40 patients across the U.S., Europe, and the UK. • TH104 demonstrated a favorable pharmacokinetic profile and a mild side-effect profile in a Phase 1 clinical trial, with positive regulatory feedback from the FDA and EMA. • The company also reported corporate achievements, including licensing agreements and the appointment of Sanam Parikh to its Board of Directors.

Semaglutide Shows Promise in Reducing Alcohol Consumption and Cravings

• A new study reveals that semaglutide, known as Ozempic and Wegovy, significantly reduces alcohol cravings and consumption in individuals with alcohol use disorder. • Participants on semaglutide experienced fewer heavy drinking days and decreased alcohol intake during lab tests compared to those on a placebo, indicating potential therapeutic benefits. • The research suggests semaglutide's effects on alcohol cravings may surpass existing treatments, offering a promising avenue for addressing the unmet needs in alcohol use disorder. • Further studies are warranted to explore semaglutide's long-term efficacy, optimal dosages, and safety, particularly for individuals without obesity or diabetes.

Pharma Update: FDA Eases CGT Path, Tharimmune Surges on EMA Feedback, Lexeo Dips on Alzheimer's Data

• The FDA is creating a more accessible regulatory environment for cell and gene therapy companies, according to executives at BioFuture 2024. • Tharimmune's stock soared following positive feedback from the EMA regarding its phase II study of TH-104 for pruritus associated with primary biliary cholangitis (PBC). • Lexeo Therapeutics experienced a stock dip despite releasing positive interim results from its phase I/II study of LX-1001 for APOE4-associated Alzheimer’s disease. • Biogen and Neomorph have entered into a partnership worth up to $1.45 billion to develop molecular glue degraders for neurological and immunological diseases.

Tharimmune's TH104 Receives Positive EMA Feedback for Pruritus in Primary Biliary Cholangitis

• Tharimmune received positive feedback from the EMA regarding its Phase 2 and Phase 3 clinical program for TH104, targeting moderate-to-severe pruritus in primary biliary cholangitis (PBC). • The EMA indicated that a hybrid application under Article 10(3) is acceptable, potentially allowing the use of existing non-clinical and safety data for TH104. • Tharimmune plans to initiate a Phase 2 multiple-ascending dose trial to assess the safety, tolerability, and efficacy of TH104 in PBC patients, with topline data expected in 2025.

EMA Endorses Tharimmune's TH104 Clinical Program for Chronic Pruritus in Primary Biliary Cholangitis

• The EMA has endorsed Tharimmune's TH104 clinical program for chronic pruritus in primary biliary cholangitis (PBC), supporting the company's development strategy. • The agency has accepted the Article 10(3) hybrid application, potentially streamlining the approval process by leveraging existing safety data. • Tharimmune plans to initiate a Phase 2 multiple-ascending dose trial soon, with topline data expected in 2025, offering hope for a new therapeutic option. • The EMA's positive feedback aligns with previous interactions with the FDA, strengthening the global development strategy for TH104.

EMA Recommends Approval of Selincro for Alcohol Dependency Treatment

• The European Medicines Agency's CHMP has recommended marketing authorization for Selincro (nalmefene), developed by Lundbeck and Biotie, for reducing alcohol consumption in alcohol-dependent adults. • Clinical trials involving 2,000 patients demonstrated Selincro's efficacy, with two-thirds of participants being first-time treatment seekers for alcohol dependency. • Lundbeck plans to launch Selincro in European markets by mid-2013, offering it as part of a comprehensive treatment program that includes psychosocial support.
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy