FDA grants priority review to MDMA-assisted therapy for PTSD

Key takeaways:

• If approved, midomafetamine would be the first MDMA- and psychedelic-assisted therapy.
• The decision was based on results from two randomized, double-blind, placebo-controlled phase 3 studies.

The FDA has accepted and granted priority review to a new drug application for midomafetamine capsules used in combination with psychological intervention for PTSD, according to a press release from Lykos Therapeutics.

The decision was based, in part, on results from the randomized, double-blind, placebo-controlled phase 3 MAPP1 and MAPP2 studies evaluating the efficacy and safety of MDMA-assisted therapy vs. placebo with therapy among patients with severe or moderate-to-severe PTSD.

Both studies met their primary endpoint of changes in PTSD severity from baseline, measured using the Clinician-Administered PTSD Scale for DSM-5. Also, the studies met their key secondary endpoint of improvement in functional impairment based on the Sheehan Disability Scale. There were no serious adverse events in the MDMA group in either study.

“Securing priority review for our investigational MDMA-assisted therapy is a significant accomplishment and underscores the urgent unmet need for new innovation in the treatment of PTSD,” Lykos Therapeutics CEO Amy Emerson said in the release. “We remain focused on working with the FDA through the review process and preparing for a controlled launch with an emphasis on quality should this potential treatment be approved.”

If approved, this will be the first MDMA-assisted and psychedelic-assisted therapy, according to the release. The FDA set a prescription drug user fee act target action date for Aug. 11.