The US 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 said, the Associated Press reported.
MDMA, also known as ecstasy or molly, is a psychedelic drug with effects that are similar to methamphetamineaccording to the National Institute on Drug Abuse.
FDA PANEL REJECTS MDMA-ASSISTED THERAPIES FOR PTSD DESPITE HIGH HOPES FROM VETERANS
Veterans organizations have long advocated for the approval of psychedelic-assisted therapies to treat mental health issues.
The U.S. Food and Drug Administration announced Friday that it has rejected MDMA as a treatment for post-traumatic stress disorder (PTSD). (iStock)
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 submitted the application for the drug, said it plans to meet with the FDA to appeal the decision, according to reports.
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“The FDA's request for another study is deeply disappointing, not only to all those who dedicated their lives to this pioneering effort, but most importantly to the millions of Americans with PTSD, along with their loved ones, who have not seen any new Treatment options “Over two decades,” Lykos CEO Amy Emerson said in a company statement.
“While conducting another Phase 3 study would take several years, we continue to maintain that many of the requests previously discussed with the FDA and raised at the Advisory Committee meeting can be addressed with existing data, post-approval requirements, or by reference to the scientific literature.”
Veterans organizations have long advocated for the approval of psychedelic-assisted therapies to treat mental health issues. (iStock)
An FDA spokesperson released a statement regarding the decision.
“As discussed at the Advisory Committee meeting, there are significant limitations in the data contained in the application that prevent the agency from concluding that this drug is safe and effective for the proposed indication.”
“The FDA's request for another study is deeply disappointing, not only to all those who dedicated their lives to this pioneering effort, but to the millions of Americans with PTSD.”
Regarding the need for additional treatments for PTSD and others mental health conditionsThe agency said it encourages further research and development to “foster innovation in psychedelic treatments and other therapies to address these medical needs.”
PharmAla Biotech, a Toronto-based company focused on the research, development and manufacturing of new MDMA derivatives, reacted to the decision in a statement sent to Fox News Digital.
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“The FDA has an important responsibility to get things right, and we believe it is acting in good faith. However, there is a vitally important need among patients for new treatments for PTSD, which must be balanced with that caution,” said Nicholas Kadysh, CEO of PharmAla Biotech.
This undated photo shows ecstasy pills courtesy of the U.S. Drug Enforcement Administration (DEA). (Reuters)
“MDMA is not only supported by a significant evidence base of published clinical trial research, but is also being actively used in patient care in two jurisdictions, Canada and Australia, supplied entirely by PharmAla.”
Kadysh added that the company is committed to Ongoing research to “convince even the most skeptical regulators that this drug is safe and effective.”
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Joe Perekupka, CEO of Freespira, the Washington-based company that makes an FDA-approved digital therapy for PTSD and anxiety, also reacted to the decision.
There have been no new treatment options for post-traumatic stress disorder (PTSD) in more than two decades, according to a statement from Lykos Therapeutics. (iStock)
“The FDA's recent decision on MDMA underscores the complex landscape of mental health treatments. At Freespira, we recognize the urgent need for more effective treatments Treatments for post-traumatic stress disorder“But we 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 medical care.” mental health care through our patient-centered model.”
Fox News Digital has reached out to the FDA and Lykos Therapeutics for comment.
