FDA slaps CRL on Lykos Therapeutics’ midomafetamine NDA

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) on the new drug application (NDA) for midomafetamine capsules for the treatment of post-traumatic stress disorder (PTSD) in adults, submitted by US hallucinogenic medicines developer Lykos Therapeutics.

The news comes as no surprise, given that, on June 4, the Psychopharmacologic Drugs Advisory Committee (PDAC) voted two to nine against MDMA-assisted therapy for PTSD, citing concerns about safety, cardiovascular risks, and issues related to functional unblinding in trial settings.

The FDA communicated that it had completed its review of the NDA and determined that it could not be approved based on data submitted to date. The FDA has requested that Lykos conduct an additional Phase III trial to further study the safety and efficacy of midomafetamine.