The US Food and Drug Administration (FDA) announced Friday that it would reject the use of MDMA as a treatment for post-traumatic stress disorder (PTSD).
The FDA said its decision was based on “significant limitations that prevent the agency from concluding that the drug is safe and effective for the proposed indication,” the Associated Press reported.
MDMA, also known as ecstasy or Molly, is a hallucinogen with effects similar to methamphetamine, according to the National Institute on Drug Abuse.
Despite high hopes from veterans, FDA panel rejects MDMA for PTSD treatment
Veterans groups have long advocated for approval of psychedelic therapies to treat mental health issues.
The U.S. Food and Drug Administration announced Friday that it would reject the use of MDMA as a treatment for post-traumatic stress disorder (PTSD). (iStock)
The FDA's decision comes about eight weeks after an FDA advisory committee voted 10-1 against the overall benefits of MDMA in treating PTSD.
The FDA has required further Phase 3 trials to confirm the drug's safety and effectiveness.
Lycos Therapeutics, the California company that filed the new drug application, said it plans to meet with the FDA to appeal the decision, according to reports.
As FDA considers approving MDMA, Marine veteran touts benefits of psychedelic drug for PTSD treatment
“The FDA's request for new studies is disappointing not only for all those who dedicated their lives to this pioneering work, but also for the millions of Americans living with PTSD and their families who have been without new treatment options for more than two decades,” Lycos CEO Amy Emerson said in a company statement.
“Although repeat Phase 3 trials would take several years, we continue to maintain that many of the requests raised in previous discussions with the FDA and advisory committee meetings can be addressed by reference to existing data, post-approval requirements, or the scientific literature.”
Veterans groups have long advocated for approval of psychedelic therapy to treat mental health issues. (iStock)
An FDA spokesperson released a statement regarding the decision:
“As discussed at the advisory committee meeting, the data included in the application have significant limitations that prevent the agency from concluding that the drug is safe and effective for its proposed indication.”
“The FDA's call for new studies is a great disappointment not only for all those who have dedicated their lives to this pioneering work, but also for the millions of Americans who suffer from PTSD.”
— Lycos Therapeutics
Regarding the need for additional treatments for PTSD and other mental illnesses, the agency said it encourages further research and development into “further innovation in psychedelic treatments and other therapies to address these medical needs.”
Pharmaala Biotech, a Toronto-based company focused on the research, development and manufacturing of new derivatives of MDMA, responded to the decision in a statement to Fox News Digital.
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“The U.S. Food and Drug Administration has an important responsibility to get things right, and we believe they are acting in good faith. However, patient needs for new treatments for PTSD are vital and must be balanced with that caution,” said Nicholas Kadish, CEO of PharmaAra Biotech.
Ecstasy pills are seen in an undated distribution photo provided by the US Drug Enforcement Administration (DEA). (Reuters)
“Not only is MDMA supported by a significant evidence base of published clinical trial studies, it is also actively used to treat patients in two jurisdictions, Canada and Australia, and is supplied entirely by PharmAla.”
Kadish added that the company is committed to continuing research to “convince even the most skeptical regulators that the drug is safe and effective.”
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Joe Perecupka, CEO of Washington-based Freespira, a company that makes FDA-approved digital therapeutics to treat PTSD and anxiety disorders, also reacted to the decision.
According to a statement from Lykos Therapeutics, there have been no new treatments for PTSD in over 20 years. (iStock)
“The FDA's recent decision on MDMA highlights the complex landscape of mental health treatment. At Freespira, we recognize the urgent need for additional effective treatments for PTSD, but we support the FDA's commitment to patient safety as it considers 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 remain focused on our mission to democratize access to advanced mental health care through our patient-centered model.”
Fox News Digital has reached out to the FDA and Lykos Therapeutics for comment.
Melissa Rudy is senior health editor for Fox News Digital and a member of the lifestyle team. Send your story tips to [email protected].
