> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Priority Review for Lykos NDA for PTSD
- URL: https://www.fdaweb.com/priority-review-for-lykos-nda-for-ptsd/
- Published: 2024-02-12T12:00:00.000Z
- Updated: 2026-09-14T14:22:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156337

FDA has accepted for priority review a Lykos Therapeutics NDA for midomafetamine capsules (MDMA) used in combination with psychological intervention for treating individuals with post-traumatic stress disorder (PTSD). The agency has set an 8/11 user fee review action target date.

The submission is based on data from two randomized, double-blind, placebo-controlled Phase 3 studies (MAPP1 and MAPP2) evaluating the efficacy and safety of MDMA used in combination with psychological intervention versus placebo with therapy in participants diagnosed with severe or moderate to severe PTSD, according to the company. Both [MAPP1](https://c212.net/c/link/?t=0&l=en&o=4088251-1&h=3827034697&u=https%3A%2F%2Fwww.nature.com%2Farticles%2Fs41591-021-01336-3&a=MAPP1&ref=fdaweb.com) and [MAPP2](https://c212.net/c/link/?t=0&l=en&o=4088251-1&h=587768541&u=https%3A%2F%2Fwww.nature.com%2Farticles%2Fs41591-023-02565-4&a=MAPP2&ref=fdaweb.com) studies met their primary and secondary endpoints and were recently published in *Nature Medicine*. “No serious adverse events were reported in the MDMA group in either study,” it says.