Midomafetamine

Recent bills aim to tackle drug shortages by improving supply data accuracy and tracking drug origins, focusing on FDA reporting and international supply chains. Despite unlikely passage in the current Congress, these measures may form future legislative packages. The FDA seeks enhanced reporting to prevent shortages, while legislation also targets the scrutiny of drug imports from countries like China.

UCLA Health analysis suggests MDMA-assisted therapy could improve outcomes for trauma-related conditions in military personnel, enhancing self-esteem, social connections, and neural plasticity, despite FDA rejection for PTSD treatment.

Thai police detained 124 people in underwear at a Bangkok drug party, finding 31 with illegal narcotics. 66 tested positive, mostly men, including 5 foreigners. Police seek court permission to extend questioning for drug suspects.

FDA approved Madrigal's Rezdiffra for NASH, Italfarmaco's Duvyzat for DMD, and Cobenfy for schizophrenia. Genentech's Itovebi was approved for breast cancer. Lykos Therapeutics' MDMA for PTSD was rejected, leading to company reorganization.

The VA plans to study MDMA's effects on veterans with PTSD and alcohol use disorder, marking its first funded psychedelic-assisted therapy study since the 1960s. MDMA-assisted therapy received FDA's Breakthrough Therapy Designation in 2017 but faced disapproval in 2023 due to study design and health risks. A $1.5 million grant will fund a 2025 study at VA centers in Rhode Island and Connecticut, aiming to reduce stigma and explore MDMA's potential as an additional treatment option.

The U.S. Department of Veterans Affairs plans to study MDMA's effects on veterans with PTSD and alcohol use disorder, marking the first VA-funded psychedelic therapy study since the 1960s. Despite FDA's recent denial of MDMA-assisted therapy approval, the VA awarded a $1.5 million grant for a 2025 study at two medical centers. The study aims to explore MDMA's potential as a regulated, alternative therapy, emphasizing the importance of accompanying therapy. Concerns remain about potential abuse if MDMA is reclassified.

The podcast discusses the psychedelics industry's current state, focusing on clinical trials for psilocybin therapies by companies like Compass Pathways and Cybin. Despite reduced investor interest due to hype and regulatory challenges, positive phase 3 trial results could reignite investment. The industry faces unique hurdles, including legal and testing complexities, but companies are innovating with patents and different therapeutic approaches.

Scientists are re-evaluating psychedelics' medicinal potential, with clinical trials underway for depression, anxiety, PTSD, and more. WashU Medicine researchers aim to transform psychedelics into safe, effective therapies using modern neuroscience. A study by WashU Medicine neuroscientists showed psilocybin disrupts brain's default mode network, correlating with mystical experiences. Psychedelic-assisted therapy, combining medicine and psychotherapy, offers rapid treatment for mental health disorders. WashU's Center for Holistic Interdisciplinary Research in Psychedelics (CHIRP) supports equitable, affordable psychedelic treatments. Despite FDA's rejection of MDMA for PTSD, public and scientific interest in psychedelics remains high, with ongoing research and funding opportunities.

Veterans Affairs announces $1.5 million grant for MDMA-assisted therapy study on PTSD and alcohol use disorder among veterans, marking the first department-funded psychedelic research in over five decades. The study, to be conducted at Providence and West Haven VA Medical Centers, will be overseen by researchers from Brown and Yale Universities, with enrollment starting early next year. The five-year project aims to gather definitive scientific evidence on the efficacy and safety of psychedelic compounds.

Psychedelic drug developers face setbacks but see potential in Johnson & Johnson's Spravato success. Cybin, a Toronto-based company, benefits from FDA insights gained from Lykos and Compass's issues, advancing its Phase 3 trial for deuterated psilocin (CYB003) for major depressive disorder. Cybin emphasizes FDA-desired trial details and patient safety measures, leveraging breakthrough therapy designation for real dialogue with the agency. The expanding infrastructure for Spravato administration supports future psychedelic drug rollouts.