FDA's psychedelic reckoning
This interesting & informative article starts: "The number of psychedelic drug developers reaching Phase 2 and Phase 3 clinical trials is growing, in recognition of the level of unmet need in many mental health disorders and other conditions. Those candidates are progressing despite two setbacks that occurred this year: the first began with a contentious and emotional FDA Advisory Committee meeting on Lykos Therapeutics’ breakthrough therapy-designated MDMA candidate, and ended with an FDA Complete Response Letter (CRL) declining to approve the therapy-assisted drug without further study. The second setback arrived with Compass Pathways’ announcement of a delay in top line data from a Phase 3 pivotal trial of COMP360, Compass’s breakthrough therapy-designated psilocybin candidate targeting treatment-resistant depression. Both Lykos and Compass announced significant layoffs following those setbacks. Considered in isolation, it might appear that the buzz around psychedelic medicines has begun to wear off. A different signal, however, points to a different conclusion: Johnson & Johnson’s Spravato, a ketamine-derived product (esketamine) administered via nasal spray and first approved by the FDA in 2019, is expected to reach blockbuster status this year, and could reach as much as $5 billion annually, according to the Wall Street Journal. Aside from that precipitous growth in sales, the increased usage of Spravato has helped to build the infrastructure needed to administer new psychedelic medicines, such as expanding the number of available clinics and practitioners licensed to treat patients. All of this, including insights extracted from the setbacks at Lykos and Compass, bodes well for Cybin, a Toronto-based biopharmaceutical company which has initiated a Phase 3 pivotal trial of deuterated psilocin (CBY003) for major depressive disorder (MDD). Doug Drysdale, CEO at Cybin, chalks up the missteps at Lykos (formerly MAPS Public Benefits Corporation) and Compass to an evolving — and strengthening — knowledge base at FDA around what clinical data is required for approval, and what guardrails (REMS programs, for instance) need to be in place for safe and effective commercialization."
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