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A federal advisory committee convened today to weigh the risks and benefits of MDMA, commonly known as ecstasy, in the treatment of post-traumatic stress disorder.
MDMA is classified as a Schedule I drug under the Controlled Substances Act, and approving it is a big change. It's the first time FDA advisors have considered a psychedelic drug for medical use. The novel treatment has the potential to revolutionize a field of great interest, but critical questions loom.
About 5% of adults in the United States—about 13 million people—experience PTSD in any given year. Assumptions From the National PTSD Center. But current treatment options — including antidepressants and some specialized forms of cognitive behavioral therapy — are limited in their structure and effectiveness, and there are few options to help them respond well.
Lykos Therapeutics has promising data from two late-stage clinical trials using MDMA in combination therapy to treat PTSD. MDMA is a psychedelic drug known as an entactogen, a class of psychoactive drugs that produces emotional union, relatedness, and emotional clarity.
About 200 people took part in the Lycos trials, a treatment program that involved three eight-hour sessions in which participants took MDMA in the presence of two therapists. MDMA sessions were spaced approximately one month apart, with additional treatment sessions.
“Participants appeared to experience rapid, clinically meaningful, sustained improvement,” the US Food and Drug Administration said in a briefing. Document About studies.
But the agency raised key questions for members of the Psychopharmacological Drugs Advisory Committee, saying it “makes these data more challenging to interpret and complicate the benefit-risk assessment of this application.” In consideration.
At today's meeting, committee members will hear presentations from Lycos and the FDA along with public input as they weigh the risks and benefits of the novel treatment.
The FDA has the final decision to approve the treatment and often follows the committee's recommendations, but it doesn't have to.
The studies were designed to be double-blind, meaning that neither the participants nor the researchers knew who received the MDMA treatment and who did not. This type of research is considered the gold standard because it helps to reduce the bias of the results by reducing the influence of external factors. But MDMA's hallucinogenic effects have “profound changes” in a person's mood, and most participants knew which group they were in by the nature of their experience.
The Institute for Clinical and Economic Review, a nonprofit that conducts independent reviews of treatments, tests and procedures, also cited “significant concerns about the validity of the results” in the Lycos trials. Report Published in March. Those concerns centered on both the unblinding of the trial and the effects on patient perception.
In addition to the murky data on efficacy, there were concerns about safety data, the FDA said.
It is known to have the potential for abuse, but the FDA cautions that the study did not accurately evaluate this as an adverse event relative to the treatment program.
They suggest that illegal use of MDMA can be dangerous to heart and liver health. Phase III clinical trials It showed “significant increases in both blood pressure and heart rate” among participants, the FDA said, but some related reviews are incomplete. And liver health is evaluated in only small groups from earlier stages of clinical trials.
The questions are all common to Lycos, and the company has been in discussions with the FDA during the investigation, CEO Amy Emerson said. The advisory committee meeting is “the next big step” in the process and an opportunity to gather more information, she said.
“Such an urgent patient needs new treatment options, and we use that as our guiding light as we develop MDMA-assisted therapy,” she says. “Always, we're really committed to safety, and that's always top of mind.”
Interest in and support for the therapeutic use of psychedelics is growing. Along with MDMA, drugs such as ketamine and psilocybin mushrooms are being studied in clinical trials to treat various mental health disorders.
“Depression, PTSD, eating disorders – they're all different. You can't put these together and say, 'Psychedelics are good for this.'” said Emerson. You have to study it, you have to look at the safety and effectiveness profiles of each one, and we have to be careful not to treat these things like panaceas or magic bullets.
The Lycos treatment is the first to reach this stage in the process, and the FDA and the advisory board could set key precedents for how to proceed.
“It's early but exciting times. The promise is there, the potential is there, and we need to know with careful study and time how effective these drugs are,” said Dr. Joshua Gordon, director of the National Institute of Mental Health.
Many questions remain about the specific conditions needed to use this treatment effectively, and FDA advisers may choose to support it with different rules, or none at all, he said.
Still, even the most supportive experts warn Limitations of treatment.
“I hope the drug will be approved, but in a way that it can be provided and monitored responsibly,” said Dr. Rachel Yuda, director of the Center for Psychiatry and Risk Studies at Mount Sinai's Icahn School of Medicine. Non-FDA Advisory Committee Member. My concern is that we stop being curious, we stop asking the right questions, we stop trying to figure out the mechanisms of action, we stop trying to perfect and measure, just like we do with other treatments.
Protecting vulnerable populations who could benefit from this treatment is critical, experts say.
“There is recognition that psychedelics are particularly vulnerable to blurring the line between rigorously applied medical treatments given by experienced clinicians in well-supervised settings and recreational uses, so there is great interest in trying to get this right.” said Dr. John Alpert, House Chair and Chair of the Department of Psychiatry and Moral Sciences at the Albert Einstein College of Medicine.
“The last thing you want is for a promising treatment for a traumatic condition to be derailed by an unlimited and unmonitored range of uses.”
Also, the trials so far have excluded people who are more vulnerable to MDMA's side effects, such as teenagers and those with comorbid conditions such as schizophrenia or bipolar disorder, and it is important to continue collecting data to understand how the treatment works. There are these people.
“Any FDA approval of MDMA must be accompanied by strong regulations, strict prescribing and dispensing controls, comprehensive patient education, and ongoing surveillance and monitoring systems,” the American Psychiatric Association wrote in a letter to an FDA advisory committee.
In addition to setting precedent in mental health treatment, Lykos says the specific treatment program she studied is “labor intensive.” It requires a significant investment—both logistical and emotional—from participants and providers, which is challenged by the shortage of mental health professionals in America.
“We've never had a situation where the government did a 180 on something they thought was harmful and allowed it for a situation,” Judah said. “And then the question is, 'Are we going to use the time in a way that improves the mental health of our people?' That's what it says.
's Brenda Goodman contributed to this report.