Therapy Component Trips Up Lykos’ MDMA At US FDA AdComm For PTSD

Functional unblinding and vague psychotherapy guidance lead to two negative votes for Lykos’ pioneering psychotherapy-assisted psychedelic therapy at the US FDA’s Psychopharmacologic Drugs Advisory Committee.

MDMA
Advisory committee members raised several concerns about Lykos' proposed "entactogen." • Source: Shutterstock

Lykos’ midomafetamine NDA for post-traumatic stress disorder is pathbreaking on multiple fronts as the first psychedelic therapy to seek US Food and Drug Administration approval with the first psychotherapy-assisted drug indication. But concerns about the functional unblinding inherent in psychedelic use and frustration with the therapy component led the agency’s Psychopharmacologic Drugs Advisory Committee to overwhelmingly turn down the application on 4 June.

Midomafetamine, Lykos’ version of the long-used illicit drug MDMA, is being considered for an indication as an “entactogen,” a psychoactive...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from US FDA Performance Tracker

More from Regulatory Trackers