Opioid Use Disorder (OUD)
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New Study Shows Extended-Release Buprenorphine Safely Delivers Rapid, Clinically Meaningful Reductions in Opioid Use and Supports Abstinence in High-Risk Populations
Prnewswire· 2025-12-17 16:30
RICHMOND, Va., Dec. 17, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq: INDV) today announced results from a randomized, double-blind clinical trial published in JAMA Network Open. The study found that both the 100-mg and 300-mg monthly maintenance doses of SUBLOCADE® (extended- release buprenorphine) rapidly reduced opioid use and improved opioid abstinence and were well tolerated, with no new safety signals in individuals with moderate-to-severe opioid use disorder (OUD). Participants across both dose groups e ...
atai Life Sciences Awarded Grant from the National Institutes of Health
Globenewswire· 2025-09-18 12:00
Core Insights - atai Life Sciences has been awarded a multi-year grant worth up to $11.4 million by the National Institute on Drug Abuse (NIDA) to support the development of non-hallucinogenic 5-HT2A/2C receptor agonists for opioid use disorder (OUD) [1][2][9] Company Overview - atai Life Sciences is a clinical-stage biopharmaceutical company focused on developing effective mental health treatments, including psychedelic-based therapies for conditions such as treatment-resistant depression and social anxiety disorder [5] - The company is advancing a drug discovery program aimed at identifying novel, non-hallucinogenic 5-HT2A receptor agonists for treatment-resistant depression [5] Industry Context - OUD affects approximately 16 million people globally and incurs costs exceeding $750 billion annually, with over 120,000 opioid-related deaths occurring each year [3] - The grant highlights the urgent need for innovative and evidence-based treatment options for OUD, reflecting the ongoing crisis's impact on individuals and communities [2][3] Research and Development Focus - The grant will fund the optimization and early-stage development of atai's 5-HT2A/2C agonist program, which aims to create compounds that modulate serotonin receptors involved in addiction while minimizing hallucinogenic effects [2][3] - The funding will support lead optimization, proof-of-concept studies, and necessary toxicology and manufacturing work to file an Investigational New Drug (IND) application [2] Future Plans - If early-stage development milestones are achieved, atai plans to advance the program into a first-in-human Phase 1 study [2] - The company is committed to developing safer, polypharmacologic treatments for mental health conditions, including substance use disorders, anxiety, and depression [4]