MDMA Treatment for PTSD Shows Promise in Clinical Trial

MDMA Treatment for PTSD Shows Promise in Clinical Trial
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A biopharmaceutical company dedicated to psychedelic treatment announced last week that its clinical trial on MDMA-assisted therapy for post–traumatic stress disorder (“PTSD”) produced encouraging results. The company, MAPS Public Benefit Corporation, said that it had completed “confirmatory phase three” of the multi-site study, which “met both the primary endpoint as measured by the change from baseline in Clinician-Administered PTSD Scale for DSM-5 (‘CAPS-5’) and the key secondary endpoint of improvement in functional impairment associated with PTSD as measured by the change from baseline in the Sheehan Disability Scale (‘SDS’).” “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 of MAPS Public Benefit Corporation.  Last week’s announcement comes after the company said in November that it had completed “the second of two Phase 3 pivotal trials.”  “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,” Emerson said last week.  The study, known as “MAPP2,” was “a randomized, double-blind, multi-site Phase 3 study of the efficacy and safety of MDMA-assisted therapy for the treatment of PTSD,” the company said last week. “The study enrolled 121 participants and of those enrolled 104 were randomized to either a group that received 80 to 120 mg MDMA hydrochloride followed by a supplemental half-dose of 40 or 60 mg during three extended sessions of therapy, or a group that received placebo plus extended sessions of therapy. The MAPP2 study enrolled participants with PTSD for the 12-week treatment period. The MAPP2 participants reflected the U.S. demographics of those living with PTSD with people of color representing more…

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