Hi, Yves. As pointed out at the beginning of this article, MDMA (also known as ecstasy) is an amphetamine, not a hallucinogen. So it’s odd that an academic publication site like The Conversation would misrepresent MDMA in the headline quoted above. Could this be because promoters of psychedelics with potential for mental health treatment want to tout the groundbreaking FDA approval as approval, even if it’s not in their field?
Keep in mind that once a drug is approved by the FDA, it can be prescribed for other “off-label” uses. For example, Botox sales are almost entirely off-label. Therefore, it has been argued that being too liberal in approving psychiatric drugs could encourage overuse, as seen with Adderall. The issue with the FDA rejecting the MDMA new drug application, due to weak results and flawed study design, is that it targets the therapeutic uses of real psychedelics that are being purported to be therapeutic in applications in the pipeline.
Article by Benjamin Y. Fong, Distinguished Professor, Associate Professor, and Associate Director of the Center for Labor and Democracy at Arizona State University. conversation
Pharmaceutical company Lycos Therapeutics announced on August 9, 2024 that the Food and Drug Administration Did not approve the company’s application Use in the treatment of MDMA-assisted therapies Post-traumatic stress disorderThis is the first decision ever made on a psychedelic drug application.
Many investors and researchers Predicting the psychedelic boomMDMA is just the first of many psychedelic drugs in the drug development pipeline.
The FDA decision Psychedelic Therapy Advocates Disappointedthe stock price is A Leader in the Psychedelic Industry This announcement caused applications to plummet, but the FDA did make recommendations on how applications could be improved to help MDMA get approved in the future.
A few days later, the Journal of Psychopharmacology Three papers on MDMA-assisted therapy retractedIn particular, it noted that one clinical trial had “violations of protocol amounting to unethical conduct.”
What is MDMA and what conditions can it treat?
MDMA, or midomaphetamineMDMA is colloquially known as “Molly” or “Ecstasy.” Although technically an amphetamine, like the drug in Adderall, a treatment for attention-deficit hyperactivity disorder, MDMA is often classified as a hallucinogen. It is thought to induce more pleasure than other amphetamines, which is why it is a popular party drug. Some researchers call MDMA an “empatogen,” or “emotion enhancer.”
MDMA is currently Schedule I Drugs – That means the Drug Enforcement Administration considers it to be extremely dangerous with no accepted medical use. Numerous clinical trials Point out the benefits of using MDMA in combination with talk therapy Patients suffering from PTSDThe FDA MDMA-assisted therapy given “breakthrough treatment” status Development and review accelerated in 2017.
PTSD is 9 to 13 million people per year In the United States No new treatments Treatments for this condition have been developed over the past 20 years.
Lycos Therapeutics Submitted application for FDA approval It will begin clinical trials of MDMA-assisted therapy for PTSD in February 2024. In the trial, the drug will be combined with psychotherapy aimed at relieving patients’ emotional stress. “Inner Healing Intelligence“, which Definition of Lykos “The innate human ability to heal the wounds of trauma.”
Why did the FDA refuse to approve Lykos’ MDMA-assisted therapy?
In June 2024, An FDA advisory committee voted overwhelmingly against the proposal. The idea that MDMA has proven effective in treating PTSD in relevant clinical trials. Equally conclusive is the The committee also voted against the proposal. The benefits have been shown to outweigh the risks, such as increased blood pressure and potential for abuse.
At the time, the advisory committee took issue with several aspects of Lycos’ application. First, the committee cited issues with “functional unblinding,” which means that most people taking the trial would know whether they were taking a potent psychoactive substance, which would bias the results. This is an issue with all psychoactive drugs, and Lycos critics believe the company should have followed FDA guidelines to use an “active placebo” (a placebo that also has psychoactive effects) as a comparison in past clinical trials.
The panel also Forms of Psychotherapy Concomitant use with MDMA, ethical concerns, etc. Various types of fraud In one of the company’s studies, participants Sexual Misconduct by the therapist involved.
Although the FDA is not bound by the votes of such advisory bodies, it typically Follow their leadSo Friday’s decision wasn’t much of a surprise.
What does the FDA’s decision mean for the future of MDMA?
The FDA: Additional Phase 3 TrialsThe phase of clinical trials that rigorously demonstrates the safety and effectiveness of a particular treatment compared to standard treatments.
Lycos said it has requested a reconsideration of the decision and will discuss the FDA’s recommendations with the agency to ensure it is moving in the right direction.
Lycos CEO Amy Emerson called the decision “deeply disappointing.” “Several years.” A new test will be conducted.
However, Psychopharmacology Three papers related to this study have been retractedLycos has a tough road ahead.
How will this decision affect the approval of other psychedelic drugs?
One prominent psychedelic drug company, Compass Pathways, is currently conducting Phase 3 clinical trials and is generally considered to be the next company to gain FDA approval for a psychedelic drug. Synthetic psilocybin Things are going well: some companies are preparing for Phase 3 trials of their patented compounds.
Following the advisory committee’s ruling in June, Compass noted: Do not use drugs together With therapy like Lycos. Another company It said it has a “better study design that is aligned with FDA guidelines.”
Other psychedelic companies apparently believe they can still succeed where Lycos failed.
Do psychedelics present unique challenges?
The FDA decision More about Lykos Rather than completely rejecting the use of psychedelics for therapeutic purposes, they take a specific approach.
But developing psychedelics is an inherently difficult process. The drugs used induce a severely altered state that leaves people vulnerable. Some industry players I spoke to believe accusations of wrongdoing are nearly impossible to avoid, given the nature of the experience.
Most studies combine psychedelics with some kind of therapeutic or enhancing agent, and as the FDA has made clear, the role Evaluate drugsnot the psychotherapy that accompanies it.
The interplay between drugs and the human element of treatment is a hot topic of discussion, and Lycos’s application setbacks highlight some of the unique hurdles that companies developing psychedelic drugs face on the road to FDA approval.
