All articles tagged with #lykos therapeutics
The FDA released a complete response letter to Lykos Therapeutics' MDMA for PTSD application, citing issues like unreported adverse events, lack of durability data, and high prior MDMA use among participants, and recommended conducting new clinical trials with specific focus areas.
The FDA’s Psychopharmacologic Drugs Advisory Committee is reviewing Lykos Therapeutics’ New Drug Application for MDMA-assisted therapy for PTSD. The meeting includes presentations from both the FDA and Lykos, public comments, and a vote on two questions that could influence the FDA's decision on August 11th. Key discussions involve the role of psychotherapy, trial misconduct, patient recruitment, and safety concerns. The meeting is being live-streamed on YouTube, with periodic updates provided by Psychedelic Alpha's Founder & Editor, Josh Hardman.