The Food and Drug Administration is considering it Whether or not to approve the use of MDMAFor the treatment of post-traumatic stress disorder, also known as ecstasy. An independent advisory panel of experts will review the studies on Tuesday and is expected to vote on whether the treatment will be effective and whether its benefits outweigh the risks.
The panel will hear from Lycos Therapeutics, which has presented evidence from clinical trials in an effort to get agency approval to legally sell the drug to treat people using a combination of MDMA and talk therapy.
Millions of Americans suffer from PTSD, including military veterans, who are at high risk of suicide. No new treatments for PTSD have been approved in more than 20 years.
What is MDMA?
Methylenedioxymethamphetamine (MDMA) is a synthetic psychoactive drug first developed by Merck in 1912. After being re-synthesized in the mid-1970s alexander shulginAccording to a Bay Area psychedelic chemist, MDMA gained popularity among therapists. Early research suggested significant therapeutic potential for a number of mental health conditions.
MDMA is an entactogen or empathogen, promoting self-awareness, feelings of empathy, and social connectedness. It is not a classic psychedelic drug like LSD or psilocybin, which can cause altered reality and hallucinations. Among people who use it recreationally, MDMA is commonly known as molly or ecstasy.
In 1985, after the drug became a staple at dance clubs and rave parties, the Drug Enforcement Administration classified MDMA as a Schedule I substance, a drug with no accepted medical use and a high potential for abuse.
Does it pose any health risk?
FDA agency staff raised concerns about “significant increases” in blood pressure and pulse rates among some participants in Lycos clinical trials, saying these were risks that “could trigger cardiovascular events.”
Many experts in this field say that this drug in its pure form is generally safe and does not cause addiction.
Adverse reactions associated with MDMA when taken outside a clinical setting are often due to the following: Adulteration such as methamphetamine and synthetic cathinones, which are often bath salts,
Some recreational users have reported feeling a low mood for a few days after taking MDMA, possibly caused by a temporary lack of serotonin in the brain, but experts say more research is needed.
What is the framework for approval?
In 2017, the FDA granted “breakthrough” status to MDMA-assisted therapy. This status, an acknowledgment of the drug's therapeutic promise, is intended to shorten regulatory timelines.
The original application was sponsored by the nonprofit Multidisciplinary Association for Psychedelic Studies, which earlier this year created a for-profit entity called Lycos Therapeutics to market MDMA if it received FDA approval.
The application presents an unusual challenge for the FDA, which typically does not regulate drug treatments that are combined with talk therapy — an essential part of Lycos' treatment for PTSD.
As of June 4, an advisory panel of experts is reviewing Lycos' clinical data, as well as making recommendations to the FDA based on public comments and staff analysis. The agency often follows the panel's suggestions, and a final decision is expected in mid-August.
What does a therapy session involve?
According to a report published in , about 200 patients in the Lycos clinical trials underwent three sessions — eight hours each — with about half given MDMA and half given a placebo. Naturopathy, The two sessions were four weeks apart.
Patients were also given three appointments to prepare for therapy and nine further appointments to discuss what they had learned.
To all Recent drug tests found that more than 86 percent of people who took MDMA had a measurable reduction in the severity of their symptoms. About 71 percent of participants improved so much that they no longer met criteria for a PTSD diagnosis.
Any approval by the agency would likely be restricted. The drug was studied during sessions attended by a psychiatrist and, for safety's sake, given the patients' vulnerability, by a second physician. The FDA staff analysis proposed some limitations on the drug's approval, including that it be administered only in certain settings, that patients be monitored and that adverse effects be monitored.
But doctors and therapists can still prescribe MDMA off-label, increasing its potential for treatment of other ailments, such as depression or anxiety.
How likely is FDA approval?
Although Two studies While the facts behind Lycos' application suggest that MDMA therapy led to significant improvements in patients with PTSD, the FDA staff report released last week highlighted shortcomings in the study design. Most notably, the report flagged a high percentage of participants who were able to determine whether they were given MDMA or a placebo, a phenomenon that is common in many drug trials involving antipsychotic compounds.
The Institute for Clinical and Economic Review, a nonprofit that examines the costs and effectiveness of drugs. has been criticized analyzed the studies and described the results as “inconclusive”.
Overall, the FDA analysis was largely positive, finding that participants “experienced a statistically significant and clinically meaningful improvement in their PTSD symptoms, and this improvement appears to be durable for at least several months.”
Does MDMA have other uses?
A number of studies are ongoing to explore MDMA’s potential in treating a variety of difficult mental health challenges, including obsessive-compulsive disorder and severe depression.
Dr. Joshua Gordon, director of the National Institute of Mental Health, said early data on MDMA and other psychedelic compounds have created a stir in the field of psychotherapy, especially as research has shown they can produce lasting benefits after just a few treatments.
But he warned against having too much hope. “MDMA therapy is likely to be at least as effective as other agents we have, and the effects may last for some time,” he said. “But it's not going to work for everybody. It's not a miracle drug.”