The FDA recently rejected a new drug application for treating post-traumatic stress disorder, or PTSD. The new medication was the psychedelic drug MDMA, also known by its street name ecstasy. Its technical name is midomafetamine. The company bringing it forward is Lykos Therapeutics, a spinoff from the Multidisciplinary Association for Psychedelic Studies.
Lykos designed its clinical trials to test whether psychotherapy conducted under the influence of MDMA is effective at treating this devastating condition. However, the agency pointed out that because MDMA has profound effects on mood, cognition and suggestibility, participants could readily distinguish whether they were getting the drug or a placebo. Interestingly, the FDA was actively involved in designing the clinical trials it now deems inadequate. Because Lykos tested the drug as an aid to psychotherapy, the agency may be reluctant to approve it. FDA does not regulate the practice of medicine or psychotherapy.
Do Benefits Outweigh Risks?
In addition, the agency was unconvinced that the benefits of the medication, administered in three day-long supervised psychotherapy sessions, outweigh its risks. It has asked the company to conduct another phase 3 trial if it wants the therapy to be reconsidered for approval. No doubt Lykos will discuss exactly how an acceptable trial should be structured.
Articles on MDMA Retracted:
Lykos experienced another setback this month when the journal Psychopharmacology retracted three articles relating to earlier trials. Apparently, a serious ethical violation at one of the study sites was not disclosed to the journal. According to Lykos, it notified FDA, Health Canada and the relevant Institutional Review Board, but not the editors of the journal.
What Is PTSD?
Many people immediately think of battlefield trauma when the phrase post-traumatic stress disorder is mentioned. Soldiers in Iraq and Afghanistan suffered horrific violence, and many have experienced long-lasting psychological scars.
But PTSD can be triggered by almost any emotional trauma. Victims of domestic violence frequently suffer PTSD. Any severely distressing event or series of events can lead to unrelenting symptoms. They include troubling memories that keep recurring. Flashbacks, nightmares, anxiety, irritability and anger are also common symptoms.
How Could MDMA Help Against the Trauma of PTSD?
MDMA was originally mentioned by the Merck pharmaceutical company in 1912 (Pharmazie, Nov. 2006). The drug wasn’t tested on human subjects until 1959.
Some psychiatrists in the late 1970s and early 1980s started using MDMA during psychotherapy. They believed it enhanced communication and enabled patients to gain better insights about deep-seated problems.
One article in the American Journal of Psychiatry (Nov. 1985) titled “Information on ‘Ecstasy’” describes the drug this way:
“MDMA has been labeled a psychedelic drug, but the scant published literature comparing the subjective effects of this compound to those of the ‘classic’ psychedelic drugs such as LSD, psilocybin, mescaline or dimethyltryptamine, does not clearly support the placement of MDMA in this category. Anecdotal clinical reports describe a lack of the disorientation, ego disruption, perceptual distortions, and transient psychotic states that can occur with the more powerful psychedelics, when MDMA is used in a controlled environment with careful supervision.
“We hope the furor in the media and legislatures that made research with psychedelic compounds so difficult (if not impossible) to pursue in the 1960s will not have the same effect on further rational inquiry into the mechanisms of action and clinical utility of MDMA.”
The Club Drug:
That plea by psychiatrist George Greer was made over 35 years ago. During the interim, there has been relatively little research into the use of MDMA for easing the trauma of PTSD.
That’s largely because ecstasy became popular as a club drug. The DEA banned MDMA and categorized it as a Schedule 1 drug with no accepted medical use.
What Lykos Learned About MDMA:
Researchers are starting to study MDMA again. In a phase 3 clinical trial, 90 patients with PTSD received either MDMA or placebo (Nature Medicine, June 2021). Both groups also participated in intense psychotherapy.
When they were assessed after two months, one-third of the patients on placebo had improved whereas two-thirds who received MDMA were no longer diagnosed with PTSD. The researchers emphasize that MDMA facilitates psychotherapy and is not itself a magic wand for relieving symptoms of post-traumatic stress disorder. This study and a similar one, comprising more than 100 people with PTSD, were the basis for the Lykos FDA application.
Share Your Story:
Have you suffered from PTSD? Please let others know how damaging this trauma can be in the comment section below. What have you done to overcome the psychological scars?
