Midomafetamine

Safe Supply Streaming Co Ltd. launches Safety Strips Inc. to combat fentanyl, xylazine, and drink spiking, aligning with California's AB 1013 legislation. Products available from September 25, 2024, through Greenlane Holdings' distribution network.

FDA rejection of Lykos Therapeutics’ midomafetamine (MDMA) for PTSD could delay U.S. patient access by five years, according to Terran Biosciences CEO Sam Clark.

Aaron Martin, a financial manager, found relief from depression and addiction through psychedelic treatments in Costa Rica, leading to significant lifestyle changes. The FDA's recent denial of MDMA for PTSD treatment highlights challenges in psychedelic therapy approval, though ongoing research at the University of Iowa explores psychedelics for alcoholism treatment. Experts emphasize the necessity of combining psychedelics with psychotherapy for effective mental health treatment.

A Boulder-based therapist is disappointed by the FDA's decision not to approve MDMA-assisted therapy for PTSD, despite a Phase III study showing 71% of participants no longer met PTSD criteria. The therapist argues the decision is a setback for PTSD sufferers, who often face severe symptoms and suicidal thoughts. The FDA's decision may be due to a lack of precedent for approving a therapy rather than just a drug.

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.