Psilocybin

A study estimates 5.1 to 5.6 million Americans receiving depression treatment could qualify for psilocybin therapy if approved by the FDA, based on criteria from recent clinical trials.

Over 5 million Americans could benefit if the FDA approves psilocybin as a depression treatment, according to researchers. The study estimates 56% to 62% of currently treated depression patients could be eligible for psilocybin therapy, potentially reaching 5.1 to 5.6 million people. The number could increase if untreated individuals opt for the treatment. The findings highlight the need for discussions on insurance coverage, regulatory conditions, and trained professionals to administer the treatment safely.

New research suggests psilocybin-assisted therapy could benefit millions of Americans with depression, with 56-62% of current treatment recipients potentially eligible if FDA approves. The study, involving Emory University, UW-Madison, and UC Berkeley, highlights the importance of understanding practical implementation challenges.

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.

FDA found psychoactive substances in Diamond Shruumz products, causing 158 illnesses, 63 hospitalizations, and 2 deaths. Recalled products include Dark Chocolate Bar and Birthday Cake Chocolate Bar, containing 4-acetoxy-DMT, desmethoxyyangonin, dihydrokavain, and kavain. FDA advises avoiding all Diamond Shruumz products.

Incannex Healthcare Inc. secured a $60 million financing agreement with Arena Investors, LP, including $10 million in convertible notes and a $50 million equity line of credit, to advance clinical-stage drug candidates. The funds will support ongoing clinical trials and general corporate purposes.