Trial Profile
A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Posttraumatic Stress Disorder of Moderate or Greater Severity
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 16 Jan 2025
Price :
$35
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At a glance
- Drugs Methylenedioxymetamfetamine (Primary)
- Indications Post-traumatic stress disorders
- Focus Registrational; Therapeutic Use
- Acronyms MAPP2
- Sponsors Lykos Therapeutics
Most Recent Events
- 09 Aug 2024 According to a Lykos Therapeutics media release, company will work diligently in the coming months to address FDA's concerns and to take advantage of agency processes to resolve scientific disagreements. Following the FDA meeting, Lykos expects to provide an update on next steps for the resubmission.
- 09 Aug 2024 According to a Lykos Therapeutics media release, the FDA has requested that Lykos conduct an additional Phase 3 trial to further study the safety and efficacy of midomafetamine. Lykos plans to request a meeting with the FDA to ask for reconsideration of the decision and to further discuss the agency's recommendations for a resubmission seeking regulatory approval for midomafetamine capsules.
- 09 Aug 2024 According to a Lykos Therapeutics media release, the U.S. Food and Drug Administration has issued a complete response letter for the NDA for midomafetamine capsules for the treatment of post-traumatic stress disorder adults. The FDA communicated that it had completed its review of the NDA and determined that it could not be approved based on data submitted to date.