In this Issue
- Lykos’ Path to FDA Approval Might Include a Third-Party Review of Phase 3 Data, VA Funding of Phase 3 ‘Definitely a Possibility’
- Precision Psychiatry Platform Under Pressure as Alto’s ALTO-100 Fails in MDD Trial
- Antidepressant Withdrawal Doesn’t Diminish Psilocybin Efficacy, Compass Study Suggests
- Massachusetts Miscellany: MAPS Boosts Funding for Yes on Question 4
- Czech Republic Establishes Unique Category for Low-Risk Psychoactive Substances, Skirting International Drug Controls
- Other Stories, including: Eli Lilly’s Alzheimer’s Drug Blocked from UK Coverage by NICE, Citing High Costs; SXSW’s 2025 Psychedelics Line-Up; Imperial Wins UK Government Funding for Psilocybin Study; Seaport Therapeutics Scoops $225M Series B; FDA Issues Complete Response Letter to PharmaTher; and more.
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Lykos’ Path to FDA Approval Might Include a Third-Party Review of Phase 3 Data, VA Help
Late last Friday, Lykos Therapeutics announced that it has met with the FDA regarding the future of its MDMA for PTSD program, after the agency refused to approve its New Drug Application (NDA) via an August 2024 Complete Response Letter.
In a 100-word statement the company revealed that the ‘path forward’ for the program will include an additional Phase 3 trial (which the FDA had already made clear), but could also entail an independent, third-party review of the two existing Phase 3 studies.
We asked Lykos whether this was news to them or whether it had already been discussed with the agency, but the company declined to comment.
VA Funding of Lykos Phase 3 ‘Definitely a Possibility’
According to POLITICO, VA Undersecretary for Health Shereef Elnahal said earlier this week that the agency is potentially open to the idea of helping Lykos fund that fresh Phase 3.
“That is definitely a possibility”, Elnahal is reported to have said during a roundtable discussion with reporters when asked about it.
A Lykos spokesperson told us: “We are currently working with the FDA on a path forward to get this treatment approved.” In response to Elnahal’s reported comments, the spokesperson added: “We are pleased that the VA is open to exploring ways of working together and we very much welcome the opportunity to do so”…
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