MDMA-Assisted Therapy Application Resubmitted to US FDA, MAPS Says

Resilient Pharmaceuticals has resubmitted its new drug application (NDA) for MDMA-assisted therapy for post-traumatic stress disorder to the United States Food and Drug Administration, according to the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS issued its statement on 10 August in response to a 9 August report by industry publication Psychedelic Alpha; the resubmission was subsequently reported by trade press including HCPLive on 11 August.

What has been reported

According to MAPS, the application has been resubmitted without a new Phase 3 study. “Two years after FDA rejected the initial application for MDMA-assisted therapy for PTSD, Resilient’s new NDA is being submitted without a new Phase 3 study,” MAPS founder Rick Doblin said in the statement. MAPS — which initiated and funded the original clinical research programme, completed in 2022 — noted it has no active role in Resilient’s current development programme.

Neither Resilient Pharmaceuticals nor the FDA had publicly confirmed the resubmission at the time of writing, and no review timeline has been made public. The FDA’s acceptance of a resubmitted application, and any decision date, would be separate steps that have not yet been reported.

Background

The FDA declined to approve the original application in August 2024, issuing a complete response letter that, according to MAPS’s statement at the time, asked the sponsor to conduct an additional Phase 3 trial. The company — founded as MAPS PBC, renamed Lykos Therapeutics in 2024 and then Resilient Pharmaceuticals in 2025 — has since pursued discussions with the regulator rather than new pivotal trials. In July 2026 the FDA published final guidance on psychedelic drug development, which MAPS co-executive director Betty Aldworth said “reflects the approaches MAPS developed with the FDA after decades of scientific collaboration”; the agency has scheduled a public hearing on therapeutic psychedelics for 14 September.

The Australian picture

Australia is watching this from an unusual position: since July 2023, TGA-authorised psychiatrists here have been permitted to prescribe MDMA for PTSD — a pathway that exists in few other places. A US approval, if it eventuated, would not change Australian access by itself: no MDMA product is registered on the Australian Register of Therapeutic Goods, and registration would require a sponsor to apply to the TGA. It would, however, be a significant regulatory signal for a substance Australians can currently access only through that tightly controlled clinical pathway or approved trials.

Outside those settings, MDMA remains illegal to possess or supply in every Australian state and territory. This article reports regulatory and company developments; it is not evidence about any treatment’s effects, and it is not medical advice.

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