MDMA Therapy Inches Closer to Approval

MDMA Therapy Inches Closer to Approval | The Lifesciences Magazine

A recently conducted study may provide regulators with sufficient evidence to consider the use of MDMA, also known as Ecstasy, as a potential treatment for PTSD (post-traumatic stress disorder). The study, published on Thursday, suggests that MDMA therapy is effective in reducing symptoms of PTSD.

This research represents the final trial conducted by MAPS Public Benefit Corporation, a company dedicated to developing prescription psychedelics. They intend to submit the study’s findings to the Food and Drug Administration (FDA) as part of an application seeking approval to market MDMA therapy, the psychedelic drug, as a treatment for PTSD when combined with talk therapy.

First novel treatment for PTSD

If approved, this would mark a significant milestone, as “MDMA therapy would be the first novel treatment for PTSD in over two decades,” stated Berra Yazar-Klosinski, the senior author of the study published in Nature Medicine and the chief scientific officer at the company. This development offers hope for PTSD patients.

PTSD affects approximately 5 percent of the adult population in the United States each year. Conventional therapies and medications currently assist, at best, around 50 percent of patients, according to Dr. Stephen Xenakis, a psychiatrist and the executive director of the American Psychedelic Practitioners Association, who was not involved in the study. Dr. Xenakis emphasized the urgency of the situation, stating, “My clinical experience is that too many men and women have lost hope with conventional treatments and therapies and feel the only ‘out’ for them is committing suicide. We need to do something more to help them, and MDMA therapy offers a new, potentially lifesaving option when done thoughtfully and professionally.”

Administered by numerous therapists in North America

MDMA, also known as Ecstasy or Molly, has been classified as an illegal substance since 1985, when the Drug Enforcement Administration designated it as a Schedule 1 drug, categorizing it as a controlled substance with no recognized medical use and a high potential for abuse. Prior to this classification, MDMA was administered by numerous therapists in North America and Europe for purposes such as couples counseling, personal growth, and trauma treatment.

Rick Doblin, the founder of the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit organization that owns MAPS PBC, lamented the criminalization of MDMA, emphasizing its significant therapeutic potential. He stated, “The big tragedy to point out is that it was pretty clear in the late 1970s and early 1980s that MDMA had incredible therapeutic potential. All the suffering since then, because MDMA was criminalized, is enormous.”

MAPS has been championing the legalization of MDMA therapy since 1986 and has been endorsing research into its potential for treating PTSD since 2001. Similarly, the Heffter Research Institute, a nonprofit organization, has been pursuing the same objectives for psilocybin, the active component found in magic mushrooms, since 1993.

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