The FDA rejected MDMA-assisted therapy for PTSD last week.
A major setback for psychedelic medicine, but certainly not a complete surprise to insiders and the team at Lykos Therapeutics after the decision in June by the FDA's Psychopharmacologic Drugs Advisory Committee.
The FDA asked Lykos to complete more studies, so now we will wait to see how Lykos works hand-in-hand with the FDA to make sure the trial design fits their criteria.
Lykos, and parent company MAPS, have been researching MDMA-AT for PTSD and working to get MDMA-AT approved for nearly two decades.
This is a setback, but definitely not the end for these breakthrough therapies.
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💊 MDMA-AT Gets a No from the FDA
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