Positive results were announced from a phase 3 study evaluating the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in adults diagnosed with at least moderate posttraumatic stress disorder (PTSD).
The 12-week randomized, double-blind MAPP2 study (ClinicalTrials.gov Identifier: NCT04077437) included 104 patients who were randomly assigned to receive either MDMA hydrochloride 80 to 120mg followed by a supplemental dose of MDMA 40 to 60mg during 3 extended sessions of psychotherapy or placebo plus extended sessions of psychotherapy.
Results showed that treatment with MDMA-assisted psychotherapy was effective, based on the change from baseline in Clinician-Administered PTSD Scale for DSM-5, when compared with placebo (primary endpoint). The study also met the key secondary endpoint of improvement in functional impairment associated with PTSD, as measured by the change from baseline in the Sheehan Disability Scale.
As for safety, there were no serious adverse events observed in either the MDMA or placebo treatment arms.
“The phase 3 confirmatory results support the development of MDMA-assisted therapy as a potentially new breakthrough therapy to treat individuals with PTSD, a patient population that is often left to suffer for years,” said Amy Emerson, chief executive officer, MAPS PBC. “Now with two positive phase 3 trials complete, we can add this important data to the new drug application which we expect to submit in the third quarter of this year.”
MAPS PBC announces positive results from confirmatory phase 3 “MAPP2” trial of MDMA-assisted therapy for treatment of PTSD. News release. MAPS Public Benefit Corporation. Accessed January 5, 2022. https://www.prnewswire.com/news-releases/maps-pbc-announces-positive-results-from-confirmatory-phase-3-mapp2-trial-of-mdma-assisted-therapy-for-treatment-of-ptsd-301713868.html.