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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 company believes the concerns in the CRL can be addressed without new pre-market data and is not ready to commit to conducting another Phase III trial if its appeal fails

The sponsor of midomafetamine assisted therapy (MDMA-AT) plans to request a meeting with the FDA to ask for reconsideration of the CRL and to further discuss the agency’s recommendation to conduct

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