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Positive Results Achieved from Phase III Trial of MDMA-Assisted Therapy
The MAPS Public Benefit Corporation has announced confirmatory results from its Phase III trial of MDMA-Assisted Therapy for post-traumatic stress disorder (PTSD). The clinical trial included nine sessions of integrative psychotherapy, in three of which patients received doses of MDMA or a placebo.
MAPS PBC reported clinically significant changes in patients’ scores on the PTSD scale CAPS-5 (Clinician-Administered PTSD Scale for DSM-5). Furthermore, patients’ functional impairment from the disorder was diminished, as measured by the Sheehan Disability Scale (SDS). Crucially, the study observed no serious adverse events in either the MDMA group or the placebo group.
The drug also known as ‘ecstasy’ causes the release of the neurotransmitter serotonin in the brain which is critical for the healthy functioning of the body. It triggers the release of oxytocin and prolactin, hormones that help us bond and trust others.
As of yet, MDMA-assisted therapy has not been approved by any regulatory authority, however Amy Emerson, CEO of MAPS PBC said:
“Now with two positive Phase III 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.”
The regulation space around the medicinal investigation of psychedelic drugs like psilocybin, LSD, and MDMA is thorny due to the substances’ controlled status in most of the world. However, in 2017 the US Drug Enforcement Administration (DEA) streamlined the process by which researchers can apply to study Schedule I drugs.
The same year, MAPS PBC was granted ‘breakthrough therapy’ designation by the FDA, which is designed to hasten the development of promising therapies for serious and life-threatening medical conditions.
“The Phase III 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 Emerson.
The US’s National Center for PTSD estimates about 12 million US adults live with PTSD in any given year. PTSD’s patient population includes survivors and witnesses of significant traumatic events such as war, attacks, and abuse.
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