Midomafetamine

FDA rejected Lykos Therapeutics' NDA for MDMA treatment of PTSD, citing insufficient evidence of efficacy and safety. The rejection followed an advisory committee meeting where concerns were raised about the study's functional unblinding and the combined drug-therapy approach. Lykos plans to meet with the FDA to discuss resubmission, while the broader impact on psychedelic research remains debated.

Various drugs and their statuses are listed, including IN-001 for anaphylaxis (Fast Track), Finereonone for heart failure (Phase 3), Tirzepatide for heart failure and obesity (Phase 3), TMB-001 for congenital ichthyosis (Phase 3), Bentracimab for ticagrelor reversal (Priority Review), Fabhalta for immunoglobulin A nephropathy (accelerated approval), RLS-0071 for acute graft-vs-host disease (Fast Track and Orphan Drug), CHIKV VLP for chikungunya (Priority Review), Diazoxide choline for Prader-Willi syndrome (Priority Review), Mirdametinib for neurofibromatosis type 1 (Priority Review), Setmelanotide for genetic obesity (Priority Review), AR882 for gout (Fast Track), SPN-830 for Parkinson disease (NDA review), BGB-16673 for chronic lymphocytic leukemia (Fast Track), Cabozantinib for neuroendocrine tumors (NDA review), Linvoseltamab for multiple myeloma (Complete Response Letter), Nivolumab plus ipilimumab for hepatocellular carcinoma (BLA review), Midomafetamine for PTSD (Complete Response Letter), and Tezepelumab-ekko for COPD (Breakthrough Therapy).

Federal agencies discussed new PTSD treatments, including psychedelics like MDMA and ketamine, acknowledging their potential but stressing the need for further research. The Reagan-Udall Foundation meeting highlighted growing public interest in psychedelic-assisted therapies, with stakeholders largely supporting wider access. Despite FDA's recent denial of MDMA-assisted therapy approval, there is bipartisan support and ongoing research initiatives, particularly within the VA, to explore these treatments further.

Mindstate Design Labs gains FDA and EMA approval for human trials of MSD-001, a neurotech AI-designed compound targeting specific serotonin receptors. The Phase 1 trials, to be held in Leiden, will assess safety and neural impacts using advanced techniques. Mindstate's Osmanthus platform integrates AI with 70,000 drug reports and biochemical data to design precise psychoactive effects.

Researchers believe psychedelics could treat mental health, with ongoing trials in UK and worldwide. Psilocybin shows most evidence for effectiveness, with potential benefits beyond serious conditions. Despite tight UK control, businesses invest in psychedelic treatments, anticipating global authorization.

Psilera's PSIL-006, a non-psychedelic psilocybin-based drug, shows promise in treating frontotemporal dementia (FTD) with a strong safety profile in preclinical studies, potentially paving the way for FDA approval and addressing a critical need in dementia care.

FDA advisory panel rejected MDMA-assisted therapy for PTSD due to concerns over clinical trial design, potential abuse, and misconduct allegations. April Pride, CEO of SetSet, views this as a setback for psychedelic medicine, advocating for regulatory reforms and harm-reduction education. Despite the rejection, Pride remains optimistic about the future of psychedelic medicine, expecting innovation in safer compounds and protocols.

Recreational drug use triples risk for repeat serious cardiovascular events within one year of hospitalization, according to a study presented at the European Society of Cardiology Congress 2024. The study, involving 1,392 patients, found that 11% tested positive for recreational drugs, with 7% experiencing major adverse cardiovascular and cerebrovascular events (MACCE) at one year, significantly higher among drug users (13% vs. 6%).

The Reagan Udall Foundation hosted a meeting on advancing PTSD treatments, highlighting the unmet need and discussing current clinical trials, including those for MDMA-assisted therapy. Participants emphasized the importance of representative clinical trials and the impact of trauma on lives, with some criticizing the FDA's handling of MDMA trials. Despite challenges, there is optimism for future advancements in PTSD treatment.