USAbandonedDelivery formulation

MDMA composition claims (particle size / salts / dosage form)

Bibliographic data

Jurisdiction: US
Status: Abandoned
Type: Delivery formulation
Priority date: 1 December 2022

Compounds claimed

Assignees

Resilient Pharmaceuticals

Resilient Pharmaceuticals (formerly Lykos Therapeutics, formerly MAPS PBC) is a US-based public benefit corporation developing MDMA-assisted therapy for PTSD. It was founded in 2014 by MAPS as a commercial spinout to carry MAPS MDMA research through late-stage trials and regulatory approval. After two Phase 3 trials and an NDA filing, FDA issued a Complete Response Letter in August 2024 and requested an additional Phase 3 trial before approval. The company subsequently restructured and rebranded, while the public Lykos web presence continues to describe the organisation as pursuing FDA approval for MDMA-assisted therapy. As of the June 2026 review, no public company announcement of a new pivotal trial start or NDA resubmission date was found. VA/DoD-backed MDMA/PTSD research is proceeding in the broader field, but it should not be treated as direct support for Resilient/Lykos NDA resubmission unless linked by company or FDA evidence.

Prior art & evidence

Prior art and related research that speaks to this patent, curated from the Blossom database.

Related research

Study of 3,4-Methylenedioxymethamphetamine-assisted Psychotherapy in People With Posttraumatic Stress Disorder

Study Comparing Three Doses of MDMA Along With Psychotherapy in Veterans With Posttraumatic Stress Disorder

Comparison of acute effects of 3,4-methylenedioxymethamphetamine (MDMA) with and without a supplemental booster dose in healthy participants: a double-blind, randomized, placebo-controlled, crossover study

Analysis

MDMA itself has been off-patent for decades, which left Lykos, formerly MAPS PBC, pursuing composition claims around particle size, salts and dosage form rather than the molecule. The USPTO finally rejected those US claims in early 2025.

It is a useful reminder that being first to take a compound through clinical trials does not, on its own, secure exclusivity. The therapy model MAPS pioneered was always harder to protect than a new chemical entity would be. The trials below are the phase 3 programme behind that work.