Midomafetamine

FDA hybrid meeting on PTSD therapies highlighted the urgent need for innovative treatments, with MDMA-assisted therapy trials participants sharing healing stories. MAPS hosted a press briefing featuring key thought leaders advocating for the approval of psychedelic-assisted therapies for PTSD, emphasizing the need to close the 25-year gap on new pharmacotherapies.

Psychiatry faces a high-stakes experiment with psychedelics, which could revolutionize treatments but risks damaging credibility if unsuccessful. The field nearly faced extinction in the 1960s due to anti-psychiatry movements and Freudian disenchantment, but was saved by scientific method. Now, psychedelics, once banned, are being reconsidered for their therapeutic potential, though concerns remain about scientific rigor and commercial opportunism.

FDA rejected Lykos Therapeutics' NDA for MDMA therapy for PTSD, citing insufficient evidence of efficacy and safety. Advisory Committee voted 9-2 against effectiveness and 10-1 against benefits outweighing risks. Concerns included 'functional unblinding' and psychotherapy regulation. Lykos plans to meet FDA for next steps.

FDA meeting on PTSD treatments reignited debate over delayed approval of Lykos Therapeutics' MDMA-assisted therapy. Critics, including Dr. Robert M. Grant, argue FDA's review failed, citing inconsistent guidance and unmet needs for better PTSD treatments. Despite FDA's cautious approach, veterans and researchers advocate for urgent action, highlighting the growing disconnect between FDA's stance and the insistent needs of potential beneficiaries. MAPS plans to continue Phase 3 trials and educate healthcare providers and policymakers, aiming to provide access to treatments regardless of FDA requirements.

PharmAla Biotech Holdings Inc. contracted as MDMA supplier for Johns Hopkins Medicine clinical trial. CEO Nicholas Kadysh highlights PharmAla's unique position to meet GMP MDMA quality standards. PharmAla terminates agreement with Red Light Holland on September 3, 2024. Selected to present novel molecule APA-01 at EBPS Workshop on September 26th. PharmAla focuses on research, development, and manufacturing of MDXX class molecules, including MDMA, aiming to alleviate global backlog and develop novel drugs.

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.