FDA rejects MDMA as psychedelic-based treatment for mental health, PTSD

The U.S. Food and Drug Administration (FDA) announced on Friday its rejection of MDMA as a treatment for post-traumatic stress disorder (PTSD).

The decision was based on "significant limitations" that "prevent the agency from concluding that the drug is safe and effective for the proposed indication," the FDA stated, as reported by the Associated Press.

MDMA, also known as ecstasy or molly, is a psychedelic drug with effects that are similar to methamphetamine, according to the National Institute on Drug Abuse.

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Veteran organizations have long been advocating for approval of psychedelic-assisted therapies in treating mental health challenges.

The FDA’s decision comes nearly eight weeks after an FDA advisory committee voted 10-1 against the overall benefits of MDMA in treating PTSD.

The FDA has requested another Phase 3 trial to confirm the drug’s safety and efficacy.

Lykos Therapeutics, the California company that filed the drug application, said it plans to meet with the FDA to appeal the decision, according to reports. 

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"The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades," said Amy Emerson, the Lykos CEO, in a statement from the company.

"While conducting another Phase 3 study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the Advisory Committee meeting can be addressed with existing data, post-approval requirements or through reference to the scientific literature."

An FDA spokesperson released a statement regarding the decision.

"As discussed at the Advisory Committee meeting, there are significant limitations to the data contained in the application that prevent the agency from concluding that this drug is safe and effective for the proposed indication." 

Regarding the need for additional treatments for PTSD and other mental health conditions, the agency said it encourages further research and development to "further innovation for psychedelic treatments and other therapies to address these medical needs."

PharmAla Biotech, a Toronto-based company focused on researching, developing and manufacturing novel derivatives of MDMA, reacted to the decision in a statement sent to Fox News Digital.

"USFDA has an important responsibility to get things right, and we believe that they are acting in good faith. However, there is a vitally important patient need for novel PTSD treatments, which must be balanced with that prudency," said Nicholas Kadysh, CEO, PharmAla Biotech. 

"MDMA is not only supported by a significant evidence base of published clinical trial research, but is also being actively used in patient treatments in two jurisdictions, Canada and Australia, entirely supplied by PharmAla."

Kadysh added that the company is committed to ongoing research to "convince even the most skeptical regulators that this medicine is both safe and effective."

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Joe Perekupka, CEO of Freespira, the Washington-based company that makes an FDA-approved digital therapeutic for PTSD and anxiety, also reacted to the decision.

"The FDA's recent decision on MDMA underscores the complex landscape of mental health treatments. At Freespira, we recognize the urgent need for additional effective PTSD treatments, but support the FDA’s commitment to patient safety when reviewing potential new treatments," he said in a statement to Fox News Digital.

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"We believe in the importance of diverse treatment options and will continue to focus on our mission of democratizing access to advanced mental health care through our patient-centric model."

Fox News Digital reached out to the FDA and to Lykos Therapeutics requesting comment.