Lykos’ application is for talk therapy combined with MDMA, commonly called ecstasy, as a treatment for post-traumatic stress disorder.
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.
The August target date isn’t the end of the line. Should the FDA approve Lykos’ application, the Drug Enforcement Administration must reschedule MDMA before doctors can prescribe it.
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