United States: Friday saw the US Food and Drug Administration (FDA) turning down the use of MDMA in the treatment of PTSD.
As the FDA states, the underlying case had “significant limitations” that “prevented the agency from concluding that the drug is safe and effective for the proposed indication,” as Fox News reported.
More about the MDMA
MDMA, or Ecstasy, is a new form of a drug that is in the family of methamphetamine; in the way it works, it has the effects of a psychedelic, as the National Institute on Drug Abuse describes, as Fox News reported.
Although veterans‘ organizations have gradually been lobbying for the regulation of psychedelic-enhanced treatments for mental disorders.
The FDA decision was made about eight weeks after the FDA advisory committee voted 10-1 against the prospects of MDMA in the management of PTSD. In return, the FDA has asked for another Phase 3 trial to prove the drug’s efficacy and safety.
What more are the experts stating?
Lykos Therapeutics, the California-based firm that applied for the drug, said it will seek a review of the ruling with the FDA, as reported.
According to Amy Emerson, the Lykos CEO, while making a statement on behalf of the company, “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,” as the Fox News reported.
Moreover, “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,” as he continued.
A statement by an FDA spokesperson said that its 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.”
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.”
Furthermore, it added that there is a need for more treatments for PTSD treatment, as well as other mental health issues, as the agency urges for more R&D to “further innovation for psychedelic treatments and other therapies to address these medical needs.”
PharmAla Biotech is a Toronto-based company that works towards researching, developing, and manufacturing new derivatives of MDMA; where it was quick to respond to the verdict by stating Fox News Digital.
The CEO of PharmAla Biotech, Nicholas Kadysh, said, “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.”
Moreover, Kadysh further added, “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.”
He continued that the company is also focusing on research to “convince even the most skeptical regulators that this medicine is both safe and effective.”