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Home » Molly goes lightly (not): FDA hits Lykos with CRL in PTSD
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Molly goes lightly (not): FDA hits Lykos with CRL in PTSD

Aug. 12, 2024
By Randy Osborne
Speculation about potentially wider meaning among developers of psychedelic drugs was reignited after the complete response letter (CRL) from the U.S. FDA to Lykos Therapeutics Inc. for midomafetaminecapsules, which the company wants to use in combination with psychological intervention to treat post-traumatic stress disorder (PTSD). CEO Amy Emerson called the FDA move “deeply disappointing,” adding that San Jose, Calif.-based Lykos plans to request a meeting with the FDA to ask for reconsideration.
BioWorld Regulatory Neurology/psychiatric Small molecule U.S. FDA

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