Key points
FDA advisory panel votes against MDMA psychedelic science, but its approval by the agency is a possibility.
A new study of ketamine therapy for PTSD, awaiting peer review, shows high efficacy and safety for PTSD.
There’s much to learn about psychedelic safety from how we currently deliver ketamine.
As a Drug Enforcement Administration (DEA)-licensed medical doctor who has administered ketamine nearly 10,000 times to people with mental health conditions, my team and I are frequently asked how ketamine compares to methylenedioxy-methylamphetamine (MDMA) and other psychedelic therapies for post- traumatic stress disorder ( PTSD ). In recent years, there’s been major momentum and enthusiasm for emerging therapies like MDMA for PTSD. But a meeting of Food and Drug Administration (FDA) advisors recently created new uncertainty for the psychedelic therapy field, as the non-regulatory, independent advisors cast a decisive “no” vote on the safety and efficacy of MDMA therapy,
These results came as a surprise to many, given the strong data on MDMA published across multiple studies in the top science journal Nature . Meanwhile, Australia has recently authorized MDMA and psilocybin as medicine—and in Switzerland, MDMA and psilocybin have been prescribable by registered physicians for over 10 years. Clearly, there is reason to believe that MDMA and other psychedelics show strong promise for individuals seeking new options.
Many of the FDA advisors’ issues had more to do with how we design clinical trials for these complicated substances than with the therapy itself; it is difficult to “blind” a study when the agent under investigation produces such distinctive effects. Ultimately, the FDA may still approve MDMA as soon as August. The situation is not unprecedented; in one-third of instances when FDA advisors vote no, the agent is nevertheless approved for use.
Given the recent uncertainty about the fate of MDMA, it’s a question with a significant impact; in today’s mental health crisis, nearly one in ten Americans will suffer from PTSD, and existing treatment options are ineffective for approximately 50% of people. While there is not one solution right for everyone, we must educate the public in anticipation of new […]
The Truth About Using Psilocybin For Depression
Health What is really needed is a comparison of the
