An FDA approval of 3,4-Methylenedioxy-methamphetamine (MDMA)–assisted therapy would require the Drug Enforcement Administration to reschedule MDMA in acknowledgement of its medical use, making it available for prescription medical use.
Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation (MAPS PBC) submitted a new drug application (NDA) for 3,4-Methylenedioxy-methamphetamine (MDMA)—in the form of midomafetamine capsules—in combination with psychological intervention, which includes psychotherapy and other psychiatric services, for the treatment of posttraumatic stress disorder (PTSD).
If the NDA is approved, the approval would trigger a rescheduling of MDMA from Schedule I to a schedule that would acknowledge MDMA’s medical benefit. This rescheduling would also support MDMA’s availability for prescription medical use.
“The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades," said Amy Emerson, chief executive officer, MAPS PBC, in a press release. "If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, which we hope will drive additional investment into new research in mental health.”
In 2017, the FDA granted Breakthrough Therapy designation to MDMA. With the application for the NDA, MAPS PBC also requested the FDA grant Priority Review. Following the NDA submission, the FDA will have 60 days to determine whether the NDA will be accepted for review and whether it will be granted priority review (6 months) or standard review (10 months).
In the NDA submission, MAPS PBS included results from 6 phase 2 and 2 phase 3 studies investigating the use of investigational MDMA-assisted therapy for PTSD. The phase 3 studies, MAPP1 (NCT03537014) and MAPP2 (NCT04077437), assessed the efficacy and safety of MDMA-assisted therapy vs placebo with psychotherapy in participants diagnosed with PTSD. In the MAPP1 trial, participants were selected who were diagnosed with moderate PTSD, and in MAPP2, participants were selected who were diagnosed with moderate to severe PTSD.
Both MAPP1 and MAPP2 met their primary end points as measured by the change from baseline in Clinician-Administered PTSD Scale for DSM-5, as well as the key secondary end points of improvement in functional impairment associated with PTSD, which was measured using the Sheehan Disability Scale. In both trials, no serious adverse events were reported in the MDMA cohorts.
In all 8 trials included in the NDA, MDMA-assisted therapy was studied as an acute treatment that included 3 treatment cycles over a 12-week period. During each treatment cycle, investigators included 1 medication session and 3 integration sessions. During the former, a patient would self-administer MDMA while at least 1 health care professional (HCP) supervised; this HCP also provided psychotherapy and other supportive services. Following the medication session, investigators included 3 integration psychotherapy sessions to process the patient’s experience. During the 12-week period, there were also 3 preparatory sessions included.
MDMA is an entactogen, which is a part of a class of psychoactive drugs that can induce experiences of emotional communion, oneness, relatedness, emotional openness; these experiences are thought to have potential for treating various medical conditions, such as PTSD. MDMA also has a history of being used by mental health providers in conjunction with psychotherapy in the 1960s and 1970s, as MDMA was found to support patients' processing of difficult emotions and experiences. However, the Drug Enforcement Administration placed MDMA as a Schedule I drug under the Controlled Substances Act in 1985, which prevented its further use as a medical treatment. In the 2000's, placebo-controlled studies were conducted, with MAPS at the helm of much of these efforts to examine the safety and efficacy of MDMA-assisted therapy.
“Today is a historic day for health care in the United States as for decades we have seen the global mental health crisis consume our most vulnerable populations with little to no progress towards a viable cure,” said Cody Shandraw, managing partner of Ambria Capital and president and co-founder of Healing Realty Trust. “MDMA-assisted therapy represents a new day in how mental and behavioral health is treated in our country, and we applaud the entire MAPS organization on their leadership and determination to achieve this result.”
MAPS PBC Announces Submission of New Drug Application to the FDA for MDMA-Assisted Therapy for PTSD. San Jose: MAPS Public Benefit Corporation; December 12, 2023. Accessed December 12, 2023. https://www.prnewswire.com/news-releases/maps-pbc-announces-submission-of-new-drug-application-to-the-fda-for-mdma-assisted-therapy-for-ptsd-302011980.html