Midomafetamine

Compass Pathways delays Phase III readouts for its psilocybin therapy for treatment-resistant depression to 2025 and 2026, resulting in a 30% workforce reduction. The decision, influenced by increased regulatory scrutiny on functional unblinding and logistical complexities, aims to protect trial integrity. COMP360 has shown promise in earlier studies, with significant depressive symptom reduction lasting up to 12 weeks.

The FDA's delay in approving MDMA-assisted therapy for PTSD highlights ongoing challenges in psychedelic medicine, but experts at HLTH 2024 suggest continued research and state initiatives may address FDA concerns, aiming for broader availability and insurance coverage.

On September 6, 2024, the Reagan-Udall Foundation for the FDA held a public meeting on advancing PTSD treatments, including psychedelics. Representatives from the FDA, SAMHSA, DoD, and VA discussed their initiatives, emphasizing the unmet need for effective PTSD treatments. The meeting followed the FDA's denial of Lykos Therapeutics' NDA for MDMA-AT, sparking public disappointment. The meeting highlighted federal efforts to advance PTSD research and treatment, including psychedelic research, and the urgent need for more effective mental health treatments.

A WA clinic trials MDMA-assisted therapy for treatment-resistant PTSD, with patients undergoing the therapy for 3-4 months in a safe, controlled environment. MDMA calms the brain's fear centre, enabling patients to work through traumas.

Psilocybin, the active ingredient in 'magic mushrooms,' is compared to the antidepressant escitalopram in a six-month trial for depression. Psilocybin showed greater flexibility in brain states and higher well-being scores, but both treatments had comparable depressive symptom improvements. Critics argue for more extensive trials and addressing issues like cost and patient selection before widespread use.

In Singapore, harsh drug laws lead to forced rehab in austere conditions for users like Kim, who faces trafficking charges. The Drug Rehabilitation Centre, run by the Prison Service, houses inmates in concrete cells for at least six months, aiming to deter drug use through strict rehabilitation programs. Critics argue the system is inhumane, focusing on shame rather than addressing root causes of addiction.

FDA issued a Complete Response Letter to Lykos Therapeutics for midomafetamine capsules (MDMA) for PTSD, citing insufficient data. Despite concerns about efficacy and safety, experts remain hopeful for future approval. The FDA also released draft guidelines for psychedelic drug research, emphasizing proper study design and safety assessments.

MindMed plans pivotal LSD study for generalized anxiety disorder, aiming to innovate stagnant anxiety treatment landscape with MM-120, a pharmacologically optimized form of LSD, which showed promising Phase 2b results. The company envisions a treatment model similar to Spravato but with potentially fewer restrictions, targeting a growing network of interventional psychiatry clinics.