MDMA, a psychedelic drug known for inducing emotional connection, attachment, and openness, could potentially be used to treat PTSD in conjunction with therapy. This new proposal was recently submitted to the FDA by MAPS Public Benefit Corporation.
The FDA has 60 days to decide whether they will accept a new drug application or an NDA for further investigation and potentially speed up the approval process. In 2017, the FDA awarded MDMA the status of "Breakthrough Therapy," which promotes the development and testing of medications for severe illnesses, indicative of MDMA's potential improvements over current treatments for PTSD.
Two studies involving 90 and 104 participants reported a significant reduction in PTSD symptoms and impairments resulting from MDMA as compared to a placebo. MAPS announced that they have completed six advanced-stage clinical studies testing MDMA for PTSD treatment.
CEO of MAPS, Amy, stated, "Our NDA submission marks the pinnacle of over 30 years of clinical research, advocacy, collaboration, and engagement aimed at providing potential new options for adults with PTSD, a patient group traditionally lacking options for decades."
Current PTSD treatments consist mainly of antidepressants and certain forms of cognitive behavioral therapy. Although these approaches may be beneficial, their effectiveness varies among individuals. People who don't respond to these treatments have few alternative choices.
If the FDA allows MDMA for this purpose, it would need to be rescheduled off the DEA's list I as it currently lacks recognized medical use by the U.S. Drug Enforcement Administration.
According to MAPS, the timeline for this process could be impacted by the FDA's approval of MDMA. MDMA is currently controlled under the Controlled Substances Act, but studies have shown substantially higher remission rates with MDMA-assisted therapy compared to placebo.
Relevant MAPS Information
MAPS has played a critical role in the development and testing of MDMA-assisted psychotherapy for PTSD. They have:
- Raised $240 million for research and development of MDMA-assisted psychotherapy
- Conducted phase 3 clinical trials, demonstrating the therapy's potential benefits
- Engaged with regulatory authorities to ensure ethical and procedural compliance
- Advocated for MDMA-assisted psychotherapy and addressed concerns from the FDA
Despite the stalled NDA approval process, MAPS and Lykos Therapeutics continue their efforts to bring MDMA-assisted psychotherapy to adults with PTSD, aiming to fulfill the FDA's requirements and gain approval for this promising treatment option.
