MedPath

Naltrexone

Generic Name
Naltrexone
Brand Names
Contrave, Embeda, Vivitrol
Drug Type
Small Molecule
Chemical Formula
C20H23NO4
CAS Number
16590-41-3
Unique Ingredient Identifier
5S6W795CQM
Background

Derivative of noroxymorphone that is the N-cyclopropylmethyl congener of naloxone. It is a narcotic antagonist that is effective orally, longer lasting and more potent than naloxone, and has been proposed for the treatment of heroin addiction. The FDA has approved naltrexone for the treatment of alcohol dependence.

Indication

Used as an adjunct to a medically supervised behaviour modification program in the maintenance of opiate cessation in individuals who were formerly physically dependent on opiates and who have successfully undergone detoxification. Also used for the management of alcohol dependence in conjunction with a behavioural modification program.

Associated Conditions
Alcohol Dependency, Cholestatic pruritus, Obesity, Opioid Dependence, Severe Pain

SP-102 Shows Clinically Meaningful Results for Sciatica Treatment in CLEAR Trial Analysis

• Scilex Holding Company presented post-hoc analysis of the C.L.E.A.R. trial demonstrating clinically meaningful safety and efficacy of SP-102 (SEMDEXA™) for lumbosacral radicular pain at the ASIPP Annual Meeting. • The analysis showed clear separation between SP-102 and placebo in multiple endpoints, with enhanced results in the modified intent-to-treat population that received confirmed study drug. • SP-102's viscous gel formulation was specifically designed as a safer alternative to current off-label products that carry warnings about potentially dangerous and life-threatening adverse events.

FDA Grants Orphan Drug Designation to Scilex's Liquid Colchicine for Pericarditis Treatment

• Scilex Holding Company has received FDA orphan drug designation for colchicine in treating pericarditis, potentially providing seven years of market exclusivity upon approval. • Gloperba®, Scilex's liquid oral colchicine formulation, offers advantages for patients with swallowing difficulties and allows for more precise dosing adjustments, particularly beneficial for those with renal or hepatic impairment. • Pericarditis, an inflammation of the membrane surrounding the heart, affects fewer than 200,000 individuals in the United States and represents a significant unmet medical need in cardiovascular care.

EMA Confirms Mysimba's Cardiovascular Safety for One-Year Use in Weight Management

• The European Medicines Agency has reaffirmed Mysimba's positive benefit-risk profile for cardiovascular safety, but only for treatment duration up to 12 months due to limited long-term data. • Mysimba, a combination of naltrexone and bupropion, is approved for weight management in adults with obesity or overweight conditions with related complications such as diabetes or hypertension. • Manufacturer Currax must provide annual cardiovascular safety data from the ongoing INFORMUS study involving 8,600 participants, while recently publishing a peer-reviewed study showing no excess cardiovascular risk over 4.7 years.

FDA Approves Second Manufacturing Site for CONTRAVE, Bolstering Supply Chain for Leading Oral Weight Loss Medication

• Currax Pharmaceuticals has received FDA approval for a second manufacturing site for CONTRAVE/MYSIMBA, ensuring reliable supply as global demand for obesity treatments increases. • The additional production capacity strengthens Currax's ability to maintain uninterrupted patient access to CONTRAVE, the leading branded oral weight loss medication and only Reward System Modulator (RSM) class treatment. • This strategic expansion comes amid growing obesity rates worldwide, with Currax investing in both manufacturing capabilities and clinical research to provide evidence-based treatment options.

Phenomix Sciences Revolutionizes Obesity Treatment with Precision Medicine Approach

• Phenomix Sciences has developed MyPhenome™, a saliva-based genetic test that identifies specific obesity phenotypes, enabling personalized treatment approaches for better patient outcomes. • Research reveals three major obesity subtypes - Hungry Gut, Hungry Brain, and Emotional Hunger - each requiring different therapeutic interventions, with GLP-1 medications showing varying effectiveness across subtypes. • The company is partnering with pharmaceutical companies to enhance drug development and clinical trials, potentially revolutionizing obesity treatment through targeted therapies similar to oncology's precision medicine model.

FDA Removes Ozempic and Wegovy from Shortage List, Sparking Legal Challenge from Compounding Groups

• The FDA has officially removed Novo Nordisk's semaglutide products, Ozempic and Wegovy, from its drug shortage list after being listed since 2022, signaling improved supply availability. • Compounding groups have filed a lawsuit challenging the FDA's decision, arguing it was made without proper stakeholder consultation and despite ongoing supply challenges acknowledged by Novo Nordisk. • The legal dispute highlights broader tensions between pharmaceutical manufacturers and compounding facilities over access to semaglutide for treating type 2 diabetes, obesity, and cardiovascular disease.

WEGOVY's Market Dominance Grows with Expanded Cardiovascular Indication and Strong Clinical Results

• Novo Nordisk's WEGOVY has secured FDA approval for cardiovascular risk reduction in March 2024, becoming the first obesity medication authorized to reduce cardiovascular death, heart attack, and stroke risks. • Phase IIIb STEP UP trial demonstrates superior efficacy of WEGOVY 7.2mg compared to 2.4mg dosage, showing significant weight loss benefits at 72 weeks in adults with obesity. • WEGOVY generated impressive US sales of $6.4 billion in 2024, with market presence now extending to over 15 global markets including recent approval in Japan.

EMA Recommends Approval for New Cancer Treatments and Vaccines

• The European Medicines Agency (EMA) has recommended eight new products for EU-wide approval, expanding treatment options for various conditions. • Several cancer treatments have received positive recommendations, potentially offering new hope for patients with different types of malignancies. • A new antiparasitic combination has been endorsed for use in non-EU markets, addressing a critical need in regions affected by parasitic infections. • The EMA is also reviewing new safety information regarding Leqembi, an Alzheimer's disease treatment, ensuring ongoing monitoring of its benefit-risk profile.

Scilex Seeks FDA Approval for ELYXYB in Acute Pain Management

• Scilex Holding Company has submitted a Supplemental New Drug Application (SNDA) to the FDA for ELYXYB in acute pain management. • ELYXYB, an oral solution of celecoxib, has demonstrated significant pain relief in a study involving post-dental surgery patients. • The company aims to provide a non-opioid alternative for acute pain, addressing the need for opioid-sparing pain management. • The FDA's decision on the SNDA will determine ELYXYB's role in the $3 billion U.S. acute pain market.

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.
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