'MDMA Therapy Gets Support From Prominent Research Group As FDA Weighs Action' - Green Market Report
The paper noted that MDMA therapies have been proven safe and effective by multiple studies.
As an August deadline for the U.S. Food and Drug Administration looms regarding approval for psychedelic therapies, a coalition of well-known scientific researchers took it upon itself to publicize its support for midomafetamine (MDMA)-based treatment for patients with post-traumatic stress disorder.
In an online consensus statement, 23 medical doctors and researchers urged the FDA to accept MDMA therapy for PTSD, noting that more than 17 U.S. military veterans commit suicide each day due to PTSD, Drug Discovery & Development reported.
"The need for a more effective therapy for PTSD is urgent," the group wrote in the white paper. "We face a severe global mental health crisis, including an estimated 13 million Americans who are suffering from PTSD. Current therapies for PTSD fail to achieve remission in over half of patients who are treated."
The paper was signed by doctors and researchers from, among other institutions,:
- Harvard Medical School
- University of Chicago
- San Francisco VA Medical Center
- New York University Grossman School of Medicine
- Boston University School of Medicine
- University of California Berkeley
The paper – which came after an FDA advisory committee last month recommended against FDA approval for an MDMA-based therapy from Lykos Therapeutics – asserts that all phase 3 clinical trials involving MDMA therapy "have shown substantial evidence of efficacy with a consistency of results across the fifteen different study sites and across various patient subgroups."
"The findings provide ample evidence of the efficacy of (MDMA)-assisted therapy for PTSD," the scientists wrote. "Our assessment is that the benefits of (MDMA)-assisted therapy outweigh the risks and that (MDMA) is now approvable."
The paper noted that MDMA therapies have been proven safe and effective by multiple studies, and noted that phase 3 trials have shown "a clinically meaningful reduction in PTSD symptoms."
In two of the phase 3 trials, the paper noted, "87% of participants in the (MDMA) group experienced a clinically meaningful response, 69% no longer met the diagnostic criteria for PTSD, and 40% achieved remission."
MDMA's relative safety was also not truly in question, the paper asserted, noting that the drug was "used in psychotherapy from the late 1970s until 1985, when it was placed in Schedule I for reasons unrelated to its clinical safety or efficacy."
In clinical trials, however, "there were no serious adverse events" for patients participating from the drug itself, the paper reported.
Australian authorities have already approved some psychedelic therapies, including MDMA and psilocybin – for certain patients, Bloomberg reported recently.
The FDA is slated to rule on a new drug application for Lykos Therapeutics' MDMA-therapy by Aug. 11.