MAPS Public Benefit Corporation (MAPS PBC), the nonprofit’s private biopharmaceutical arm that develops psychedelic drugs, announced positive results from the Company’s product, MAPP2 second phase 3 study evaluating MDMA-assisted therapy in PTSD.

“The confirmatory Phase 3 results support the development of MDMA-assisted therapy as a potential new breakthrough therapy for the treatment of individuals with PTSD. Now that two positive Phase 3 studies have been completed, we can add this important data to the new drug application, which we expect to submit in the third quarter of this year,” said Amy Emerson, CEO of MAPS PBC.

This Phase 3, randomized, double-blind, multi-site study evaluated the efficacy and safety of MDMA therapy for the treatment of PTSD over a 12-week period.

The company said participants reflect US demographics of the population living with the condition, with people of color accounting for more than 50% of those enrolled.

Of the 121 total subjects enrolled in the study, 104 were randomized to receive either 80 to 120 mg of MDMA hydrochloride followed by an additional half dose (40 or 60 mg) during three extended therapy sessions, or a group that received a Placebo plus extended therapy sessions.

Results met the study’s primary endpoint, measured by change from baseline in a clinically administered PTSD scale for DSM-5 (also known as CAPS-5). The key secondary endpoint of improvement in PTSD-related functional impairment as measured by change from baseline in the Sheehan Disability Scale (aka SDS).

In addition, no serious side effects were found in either the MDMA or the control group.

These results will certainly support MAPS PBC’s upcoming submission of a new drug application to the FDA, which is expected in Q3 2023. And we can also expect the full dataset to be published in a peer-reviewed journal soon as well.

It is important to clarify that MDMA-assisted therapy has not yet been approved by any regulatory body…