Core Findings - Indivior PLC announced positive results from a randomized, double-blind clinical trial of SUBLOCADE® (extended-release buprenorphine), showing rapid reduction in opioid use and improved abstinence rates in individuals with moderate-to-severe opioid use disorder (OUD) [1][7] - Both 100-mg and 300-mg monthly maintenance doses were well tolerated, with no new safety signals identified [1][7] Clinical Trial Results - Participants in both dose groups experienced a significant decrease in opioid use, from over 43 instances per week at screening to fewer than three instances per week by week three, a trend maintained through week 38 [1] - Post-hoc analyses indicated that individuals using fentanyl daily or 14 or more times per week had higher abstinence rates with the 300-mg dose compared to the 100-mg dose, suggesting a specific population that may benefit from the higher dose [2][7] Expert Commentary - Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior, emphasized the importance of adapting treatment approaches to the realities of the current opioid crisis, particularly for patients with high-frequency fentanyl use [3] Product Information - SUBLOCADE® is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine product or are already being treated with buprenorphine [4] - It should be part of a comprehensive treatment plan that includes counseling and psychosocial support [4] Safety Information - The administration of SUBLOCADE via intravenous route poses serious risks, including the potential for serious harm or death, leading to its availability only through a restricted program [8] - Common adverse reactions associated with SUBLOCADE include constipation, headache, nausea, and injection site pain, occurring in 5% of subjects [14]

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]