FDA has delivered a huge blow to MDMA therapy this week. If you have been following over the last few years, MDMA (also known as Molly) has gained increasing psychotherapy support, especially concerning PTSD. The FDA recently announced a negative ruling on MDMA therapy for PTSD. Psychedelic experts are criticizing this. They stated the agency ignored solid overall results from the clinical trials.
The FDA asked Lykos Therapeutics, which had filed a new drug application with the regulatory agency, for an additional late-stage clinical trial to further study MDMA’s safety and efficacy. An effort like this would require significant additional funding and likely take years to complete. The decision immediately drew dismayed reactions from patient advocates and experts involved in developing and studying psychedelic therapies. Jennifer M. Mitchell, a neuroscientist at the University of California, San Francisco had this to say:
“It’s a true disappointment…From my perspective, I thought we met the criteria that the FDA requested, and I absolutely stand by our data.”
Treatments like these are needed for veterans and so many others feeling despair in their lives. Lykos has not made the FDA’s letter of rejection publicly available. But in a statement, the company said that the issues the agency raised mirror those discussed in an FDA advisory committee meeting in June by a panel of psychiatric experts who had voiced concerns about MDMA’s effectiveness and safety.
One major issue the panel raised was the inability to distinguish MDMA from a placebo effect because most trial participants correctly guessed whether they received the drug or a placebo. This issue, called functional unblinding, is a well-known and common problem in many trials that involve psychoactive pharmaceuticals.