MDMA in Phase 3 Trials for FDA Approval

Phase 3 trials are already underway for MDMA as treatment for PTSD. The effort is spearheaded by MAPS, who recently underwent organizational/leadership changes and a large fundraising campaign as they prepare to capitalize on the novel treatment.

About MDMA

As you might be aware Phase 3 trials are already underway for 3,4-Methylenedioxymethamphetamine (MDMA) and could be an FDA-approved drug as early as 2023. MDMA’s first FDA indication will likely be for post-traumatic stress disorder (PTSD). FDA is allowing some patients to have access to MDMA outside of clinical trials with an expanded access program, or ‘compassionate use,’ which is typically for patients that have an immediately life-threatening condition or serious disease or condition. Because there is some evidence that suggests people with PTSD have a higher risk of suicide, MDMA has qualified for the expanded access program.

REMS Indication for MDMA

It’s too soon to know what restrictions, if any, will be imposed on an FDA-approved MDMA pharmaceutical product but Pharma Solutions suspects that there will be a Risk Evaluation and Mitigation Strategy (REMS) similar to clozapine or isotretinoin in order for healthcare providers to prescribe MDMA. A REMS is a drug safety program that generally requires prescribers and/or dispensing pharmacies to supply the patient with extra educational materials and keep track of all patients that are on the REMS therapy.

MAPS Leadership Changes & Fundraising

The organization leading the charge on FDA approval is MAPS PBC, a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit. As a PBC, it is important to realize that the company is classified as a for-profit company, although they do highlight that they place public benefit above profit. This strategic classification allows them to more easily collect donations, as individuals may assume they are a non-profit,  but also allows them to potentially undergo a IPO, and become a more traditional, publicly-traded and for-profit drug company. The leadership changes are exactly in line with their newly established goals. Victoria Hale was selected as the new Chair of the MAPS Board, an experienced leader not in non-profits, but in non-profit drug development. Additionally, the Board approved a plan for MDMA’s commercialization that was developed in collaboration with the Boston Consulting Group. The plan projects that 1 million PTSD patients will be treated with MDMA-assisted therapy within the next decade – and it is foreseeable MAPS PBC will obtain additional indications for MDMA, as well as launch additional drugs. If achieved, MAPS PBC could become one of the largest drug companies in the world.
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