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On Tuesday, the Advanced Research Projects Agency for Health (ARPA-H) held a day-long gathering related to its ibogaine funding opportunity, dubbed Accelerating Safe Clinical Evaluation of Novel Treatments: Ibogaine for Better Outcomes in Opioid Use Disorder (ASCENT-IBO, for short). That opportunity is outlined in a Sp
Welcome to our fifth Field Note. As a reminder, Field Notes are timely, candid voice notes from our Founder and Editor, Josh Hardman, that give our Pα+ readers a pulse on recent developments in psychedelic drug development, policy, and access. In this Field Note, Josh shared his notes from a busy week in Washington, D.
Compass Shares 52-Week Follow-Up and Five Training Grant Recipients Earlier this month, Compass Pathways shared topline data from Part C of its smaller, placebo-controlled Phase 3 trial, COMP005. As a reminder, COMP005 enrolled 258 patients with treatment-resistant depression (TRD) to receive either a 25 mg dose of the
Pharma Ramps Up Google Ad Spend on Psychedelic Keywords Large pharmaceutical companies appear to be ramping up U.S. Google ad spend targeting psychedelics-related keywords, with the most common ads pointing to Johnson & Johnson’s Spravato webpage. Searching for more generic terms like “psychedelic” returns results from
In a commentary published in the New England Journal of Medicine yesterday, FDA outlined what it describes as its “new framework for psychedelic drugs”. The four agency staffers kick off the article by outlining the severity of the mental health crisis in the U.S., focusing on depression and PTSD in particular, before
As potential approvals of psychedelic therapies draw closer, attention is increasingly turning to what their real-world delivery might look like. While many details remain unknown, one thing appears increasingly likely: Risk Evaluation and Mitigation Strategies (REMS) will play a significant role in shaping how FDA-app
This morning, LSD drug developer Definium Therapeutics shared positive topline data from its second Phase 3 study of its lead candidate, DT120, in generalised anxiety disorder (GAD). It’s the third positive Phase 3 readout from the company since June. Trial Design The trial, dubbed Panorama, saw 245 participants across
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