While Janssen’s Spravato is on-track to become a blockbuster drug, access to the esketamine nasal spray product continues to be a key Acchiles heel for patients and their providers. Here, through study of two recent publications and interviews with their authors, we look at variability in access to, and real-world usage of, the therapy that psychedelic drug developers are increasingly hoping to imitate ..read more

Lykos Scales Back Investigator-Initiated Trials Program, Refers Some Researchers to PharmAla • Lykos Appoints ‘Pharma Veterans’ to C-Suite • Psyence Scoops Up Clairvoyant for Peanuts • Mindstate’s Moxy Enters Phase I Trial • Embattled Braxia Bought for $180k • UK Gov. Unveils £400m Plan to Catalyse Clinical Trials • GH Research Waiting on Tox Studies to Respond to FDA’s Clinical Hold • Cydex Sues Bexson Over Psychedelic Salt Patents • and more ..read more

Josh sits down with the man drafted in by Lykos to plot a path to resubmitting its MDMA application. They talk about Hough’s experience in developing Spravato to eventual approval and how that might inform any future clinical development of MDMA, Hough’s thoughts about the FDA’s verdict and the AdComm that preceded it, what a future Phase 3 program might look like, and more ..read more

In the second of a two-part series, we look at key trial design features FDA is expected to require of any future Phase 3 study from Lykos. Here, we run through how the MDMA drug developer will be expected to account for euphoria and other ‘positive’ adverse events, address selection bias, and favour larger academic and medical facilities as trial sites over private practices. What’s more, the company might be expected to outsource much of the trial's day-to-day operations ..read more

Lykos CEO Provides AdComm Feedback to FDA Commissioner • Cybin Plans to Fight Functional Unblinding with ‘Firewall’ • Doblin Charts a Future for MAPS • DEA Plots Ketamine Crackdown • Colorado Closes First Round of Rulemaking for State Psychedelics Program • and more ..read more

As the dust settles on FDA’s decision to not approve Lykos Therapeutics’ MDMA-assisted therapy for PTSD, we look at what the agency expects to see in the fresh Phase 3 study that it requested in its Complete Response Letter. In the first of a two-part series, we look at active placebos and evidence-based psychotherapies ..read more

Vicente LLP walk us through some of the busiest weeks since the Natural Medicine Advisory Board's work began, with more than ten meetings having taken place since the last Bulletin ..read more

Following FDA’s rejection of Lykos Therapeutics’ MDMA-assisted therapy for PTSD New Drug Application the company has announced a major reorganisation which sees around three-quarters of its staff laid off, the departure of MAPS founder Rick Doblin from the Board, and the appointment of a pharma veteran to oversee the resubmission process ..read more

MindMed Tops Up Healthy Cash Balance with $75M Raise; Eyes Adding Depression to Pipeline? • atai Approaches Phase 2 for DMT and R-MDMA Candidates • Compass’ Phase 3 Program Generally On-Track, Potential for Slight Delay on Readout • European Psychiatrists Remain Open to Psychedelics, Research • and more ..read more

Josh delves into FDA’s appeal process with regard to Lykos Therapeutics’ development program, and covers the trio of journal article retractions that have cast another shadow over the company’s published studies. Plus: We assess the fallout beyond Lykos, as psychedelic drug developers wrestle over the role of psychotherapy in their protocols, fast followers assess their strategies, and would-be psychedelic therapy delivery companies face a substantial delay ..read more