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The US Food and Drug Administration has rejected an application for MDMA, commonly known as ecstasy, to treat PTSD. News release From drug sponsor Lykos Therapeutics. The agency said the agency has requested “an additional phase 3 trial” to further study the treatment's safety and effectiveness.
Lycos' first application came with positive data from two delayed clinical trials that used MDMA in combination with talk therapy to treat PTSD. About 200 people participated in the Lycos trials, a treatment program that consisted of three eight-hour sessions in which they took MDMA in the presence of two therapists. MDMA sessions were spaced one month apart, with additional talk therapy sessions.
MDMA is an entactogen, a class of psychoactive drugs that produces experiences of emotional rapport, rapport, and emotional clarity.
This is the first time the FDA has considered a psychedelic drug for medical use. The novel treatment has the potential to revolutionize a field of great interest, but the review process has raised questions about how it should be used in a clinical setting. MDMA is currently classified under the Controlled Substances Act as a Schedule I drug, or a prohibited substance with “currently unacceptable medical use and high potential for abuse.” Reclassifying the drug to a lower level is a significant change involving many federal agencies.
In June, an independent FDA advisory committee voted overwhelmingly against the treatment, citing concerns about the integrity of certain trials prepared for review. In reviewing the trial data from Lykos Therapeutics, many of the committee members applauded the discovery and potential of this line of therapy but raised critical concerns – particularly regarding biased data on safety and efficacy data. They also said it was difficult to estimate how much the accompanying speech therapy contributed to the results, an area the FDA does not regulate.
“Participants appeared to experience rapid, clinically meaningful, sustained improvement,” the FDA wrote in a brief. Document About the studies before the committee meeting.
In addition to murky data on efficacy, there were concerns about safety data, the FDA said at the time.
MDMA is known to have abuse potential, but the FDA cautioned that the study did not properly evaluate this as an adverse event in terms of the treatment regimen.
They suggest that illegal use of MDMA can be dangerous to heart and liver health. Phase III clinical trials showed “significant increases in both blood pressure and heart rate” among participants, the FDA said, but some related evaluations were incomplete. And liver health is evaluated in only small groups from earlier stages of clinical trials.
Lycos said on Friday that it could take years to conduct further testing, but that it is confident that the concerns raised by the FDA and its consultants will be addressed. Lykos said he plans to discuss the recommendations with the agency and ask it to reconsider.
“Lycos will work diligently in the coming months to address FDA's concerns and use the agency's processes to resolve scientific disagreements,” the company said in a Friday news release. “Following the FDA meeting, Lycos expects to provide an update on the next steps for the resubmission.”
About 5% of adults in the United States—about 13 million people—experience PTSD in any given year, according to Assumptions From the National PTSD Center. But current treatment options, such as antidepressants and some specialized forms of cognitive behavioral therapy, are limited in their scope and effectiveness, and there are few options to help those who don't respond well to them.
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Veterans groups said they were “incredibly disappointed” by Friday's FDA decision.
“It's hard to see how the FDA's decision could be justified when it has so many tools to slow caution against this novel treatment, which could have been justified at least with the necessary safety data collection and post-marketing. studies, as well as a more restrictive risk reduction strategy,” Martin Steele, president of the Veterans Mental Health Leadership Coalition, and Brett Waters, executive director of Reason for Hope, said in a statement. They continue to look for underground suppliers, which is a sad and unexpected result.
“While we are confident that MDMA-AT will ultimately be approved, there is no doubt that this decision will lead to further unnecessary suffering and loss of life.”