The U.S. Food and Drug Administration (FDA) proclaimd on Friday its declineion of MDMA as a treatment for post-traumatic stress disorder (PTSD).
The decision was based on “meaningful restrictations” that “stop the agency from concluding that the drug is protected and effective for the advised indication,” the FDA stated, as inestablished by the Associated Press.
MDMA, also understandn as ecstasy or molly, is a psychedelic drug with effects that are aappreciate to methamphetamine, according to the National Institute on Drug Abuse.
FDA PANEL REJECTS MDMA-ASSISTED THERAPIES FOR PTSD DESPITE HIGH HOPES FROM VETERANS
Veteran organizations have extfinished been advocating for approval of psychedelic-aided therapies in treating mental health contests.
The U.S. Food and Drug Administration proclaimd on Friday its declineion of MDMA as a treatment for post-traumatic stress disorder (PTSD). (iStock)
The FDA’s decision comes csurrfinisherly eight weeks after an FDA advisory promisetee voted 10-1 agetst the overall profits of MDMA in treating PTSD.
The FDA has asked another Phase 3 trial to validate the drug’s protectedty and efficacy.
Lykos Theviolationutics, the California company that filed the drug application, shelp it structures to greet with the FDA to pdirect the decision, according to inestablishs.
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“The FDA ask for another study is meaningfully disnominateing, not equitable for all those who promiseted their lives to this directing effort, but principassociate for the millions of Americans with PTSD, aextfinished with their cherishd ones, who have not seen any novel treatment chooseions in over two decades,” shelp Amy Emerson, the Lykos CEO, in a statement from the company.
“While carry outing another Phase 3 study would consent disconnectal years, we still hold that many of the asks that had been previously talked with the FDA and elevated at the Advisory Committee greeting can be includeressed with existing data, post-approval insistments or thraw reference to the scientific literature.”
Veteran organizations have extfinished been advocating for approval of psychedelic-aided therapies in treating mental health contests. (iStock)
An FDA spokesperson freed a statement think abouting the decision.
“As talked at the Advisory Committee greeting, there are meaningful restrictations to the data includeed in the application that stop the agency from concluding that this drug is protected and effective for the advised indication.”
“The FDA ask for another study is meaningfully disnominateing, not equitable for all those who promiseted their lives to this directing effort, but for the millions of Americans with PTSD.”
Regarding the insist for includeitional treatments for PTSD and other mental health conditions, the agency shelp it encourages further research and lengthenment to “further innovation for psychedelic treatments and other therapies to includeress these medical insists.”
PharmAla Biotech, a Toronto-based company caccessed on researching, lengthening and manufacturing novel derivatives of MDMA, reacted to the decision in a statement sent to Fox News Digital.
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“USFDA has an vital responsibility to get leangs right, and we depend that they are acting in excellent faith. However, there is a vihighy vital fortolerateing insist for novel PTSD treatments, which must be equitable with that pdimiserablemirefulncy,” shelp Nicholas Kadysh, CEO, PharmAla Biotech.
Ecstasy pills are pictured in this undated handout ptoastyo courtesy of the United States Drug Enforcement Administration (DEA). (Reuters)
“MDMA is not only aided by a meaningful evidence base of published clinical trial research, but is also being dynamicly used in fortolerateing treatments in two jurisdictions, Canada and Australia, entidepend supplied by PharmAla.”
Kadysh includeed that the company is promiseted to ongoing research to “sway even the most skeptical regulators that this medicine is both protected and effective.”
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Joe Perekupka, CEO of Freespira, the Washington-based company that produces an FDA-consentd digital theviolationutic for PTSD and anxiety, also reacted to the decision.
There have not been any novel treatment chooseions for PTSD in over two decades, according to a statement from Lykos Theviolationutics. (iStock)
“The FDA’s recent decision on MDMA underscores the intricate landscape of mental health treatments. At Freespira, we recognize the encouragent insist for includeitional effective PTSD treatments, but aid the FDA’s promisement to fortolerateing protectedty when appraiseing potential novel treatments,” he shelp in a statement to Fox News Digital.
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“We depend in the transport inance of diverse treatment chooseions and will persist to caccess on our mission of democratizing access to proceedd mental health nurture thraw our fortolerateing-centric model.”
Fox News Digital accomplished out to the FDA and to Lykos Theviolationutics asking comment.
