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US FDA Advisory Committee Conduct Could Take Center Stage in Lykos Appeal of MDMA Rejection

 
• By Sarah Karlin-Smith

Sponsor of psychedelic PTSD treatment will try rarely successful formal dispute resolution process after receiving a complete response letter. 

image of large meeting taking place with people around a table and charts of information being displayed.
The advisory committee's focus on information not in the NDA or briefing book will be part of Lykos' CRL appeal. • Source: Shutterstock

Lykos reiterated its concerns about the “structure and conduct” of the June advisory committee meeting for its MDMA therapy for post-traumatic stress disorder as it prepares to formally challenge the US Food and Drug Administration’s 9 August complete response letter.

Key Takeaways

  • Lykos plans to use the Psychopharmacologic Drugs Advisory Committee’s conduct and the FDA’s ongoing advisory committee reform to justify reconsideration of its complete response letter.

The sponsor of midomafetamine assisted therapy (MDMA-AT) plans to request a meeting with the FDA to ask for reconsideration of...

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