Buprenorphine Hydrochloride and Naloxone Hydrochloride

FDA Approves Opvee, First Intranasal Nalmefene Therapy for Opioid Overdose

4 months ago

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.

Aquestive Therapeutics Advances Anaphylm NDA Submission and Alopecia Areata Trial

4 months ago

• Aquestive Therapeutics is on track to submit its NDA for Anaphylm sublingual film in Q1 2025, aiming to provide the first orally delivered epinephrine for severe allergic reactions. • The company is actively recruiting for the Anaphylm pediatric clinical trial, expanding access to this potential treatment across different age groups. • Aquestive's AQST-108 topical gel completed a pre-IND meeting with the FDA and is set to begin a Phase 2a trial for alopecia areata in Q2 2025.

UW-Madison Pioneers Ketamine Study for Teens with PTSD

5 months ago

UW-Madison researchers are launching a groundbreaking study to explore the use of ketamine, combined with psychotherapy, for treating adolescents with PTSD. This early-stage trial aims to assess the safety and potential therapeutic benefits of ketamine in a controlled setting, marking a significant step in psychedelic research for mental health conditions.

GLP-1 Agonists Show Promise in Addiction Treatment: Beyond Weight Loss

6 months ago

• GLP-1 agonists, initially for diabetes and obesity, are being explored for their potential in treating substance use disorders by targeting brain mechanisms. • Studies suggest GLP-1 agonists may reduce cravings for addictive substances by impacting the brain's reward system, showing potential in reducing binge drinking and opioid overdoses. • Clinical trials are underway to investigate the efficacy of GLP-1 agonists like semaglutide in treating various substance use disorders, with results expected in the coming years. • Experts emphasize that while promising, GLP-1 medications should be part of a comprehensive treatment plan, including community support and therapy, for individuals with addiction.

FDA Approves Roxybond 10mg for Severe Pain with Abuse-Deterrent Technology

7 months ago

• The FDA has approved Protega Pharmaceuticals' Roxybond 10mg for managing severe pain when alternative treatments are inadequate. • Roxybond is the first FDA-approved immediate-release oxycodone formulation with abuse-deterrent technology designed to reduce misuse via intranasal and intravenous routes. • The SentryBond technology in Roxybond makes the tablet more difficult to manipulate, potentially reducing abuse while providing pain relief. • Roxybond's approval addresses the critical need for safer opioid pain management options amid the ongoing opioid crisis, with over 108,000 drug overdose deaths reported.