FDA May Approve Ecstasy as New Treatment for Post-Traumatic Stress Disorder
- The FDA may soon approve ecstasy (MDMA) as a new treatment for post-traumatic stress disorder (PTSD).
- Clinical trials show promising results, with two-thirds of participants no longer meeting diagnostic criteria
- There are criticisms of the methodology of these clinical trials.
The prevalence of post-traumatic stress disorder (PTSD) is estimated to be 5 to 12% in the general population, according to National Institute of Health and Medical Research (Inserm). There are treatments to treat it, but they do not work for some patients. Research is therefore actively working to find new solutions.
New treatment for post-traumatic stress
And one of them could be ecstasy. Right now, the Food and Drug Administration (FDA), the American body that approves drugs, is facing a decision: whether to give the green light to the use of the psychedelic drug MDMA, also known as ecstasy, as a new medication for PTSD.
The new treatment is being made by Lykos Therapeutics Inc., a little-known company started by a nonprofit that has been advocating for the introduction of psychedelic therapy for decades.
“We are on the verge of integrating psychedelic medicine into mainstream medicine” explains Jeff George, president of Lykos, at a recent psychedelics conference in New York, whose remarks were reported in MedicalXpress.
For one day, on June 4, FDA experts and the laboratory will discuss the introduction of this new drug on the American market. The final decision is expected next August.
To make its decision, the FDA can rely on the results of two phase three trials on MDMA. They show that two months after taking the drug, two-thirds of participants no longer met the criteria for a PTSD diagnosis.
Debates over ecstasy clinical trials
The results are “significantly better than what we have seen with the currently FDA-approved antidepressants for the treatment of PTSD” says John Krystal, a psychiatrist at Yale University who was not involved in the studies.
But not everyone shares that analysis. In a 44-page report released in March, the Institute for Clinical and Economic Review (ICER) sharply criticized Lykos’ clinical trials. ICER concluded that the evidence was “insufficient” to determine the effectiveness of this drug. The ICER report indicates in particular that some participants may have felt “pushed”to report good results and not bad ones.
Following the ICER report, a petition signed by more than 70 researchers was sent to the FDA. They are requesting a public hearing to address issues with the clinical trial methodology. Lykos, for his part, responds that the FDA has approved the trial design.
Even if MDMA gets the green light from regulators, there are still several hurdles to get it to market. The drug must be delivered as part of a specific behavioral therapy, which means therapists will need to be trained up front, which iCER says will make the treatment more expensive: more than $12,000 per patient.