Politico February 14, 2024
The Food and Drug Administration has accepted Lykos Therapeutics’ new drug application for psychedelic-assisted therapy, teeing up 2024 as a potentially transformative year for psychedelic medicine.
The FDA granted the application priority review, meaning the agency will review it over six months instead of the standard 10-month timeline. The agency set a target date of Aug. 11 to decide whether to approve the application.
Lykos’ application is for talk therapy combined with MDMA, commonly called ecstasy, as a treatment for post-traumatic stress disorder.
The company, formerly known as the MAPS Public Benefit Corp., rebranded last month. MAPS’ research arm has studied MDMA as a PTSD treatment for more than 30 years. Its application marks the first time the FDA has...
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