FDA panel to review Lykos' psychedelic therapy for PTSD

07 May 2024
firstwordpharma.com
Phase 3Priority ReviewClinical Result
The psychedelic drug midomafetamine (MDMA) will face regulatory scrutiny next month when the FDA convenes an advisory panel to review its potential when combined with psychological intervention as a treatment for post-traumatic stress disorder (PTSD).
The committee is set to convene on June 4, according to Lykos Therapeutics, which developed the MDMA-assisted therapy. It added that this will be the first time in 25 years that the panel meets to review a potential new PTSD treatment.
The news comes on the heels of Lykos, formerly MAPS Public Benefit Corporation, bagging $100 million in an oversubscribed series A round earlier this year. The application, which has been granted priority review, was assigned a target action date of August 11.
The submission was based on the Phase III MAPP1 and MAPP2 trials, which both met their primary and secondary endpoints. In September, data from MAPP2 were published in Nature. The study found that MDMA-assisted therapy significantly reduced PTSD symptoms versus placebo, confirming the findings of MAPP1. No serious adverse events were reported in either.
Trial design concerns
However, a recent draft evidence report by the Institute for Clinical and Economic Review (ICER) raised concerns about the trials' design and ability to ensure proper blinding of participants to eliminate bias. The report concluded there were "many uncertainties about the balance of benefits and harms" that require careful examination.
Complicating the FDA's assessment is the hybrid nature of MDMA-assisted therapy, which involves giving the drug in capsule form in conjunction with psychotherapy.
"Certainly, there's a labelling issue there that the FDA will be interested in – who has PTSD that matches what the therapy is approved for," said David Rind, chief medical officer at ICER. "They need to really understand what the therapy is … to move forward with this as there were many therapy options in these trials, and I actually think that causes problems for how you disseminate this."
Meanwhile, the FDA panel's conclusions could reverberate across the emerging psychedelic medicine landscape. Compass Pathways is expected to publish data later this year from a Phase III trial of 800 patients given its investigational COMP360 psilocybin for treatment-resistant depression, while Cybin will also initiate its late-stage study of psilocybin analogue CYB003 to treat major depressive disorder.
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