Psychedelic drug MDMA faces FDA panel in bid to become first PTSD medication

WASHINGTON – Federal health consultants are weighing the unprecedented approval of MDMA, the mind-altering drugas a treatment for PTSD – part of a decades-long effort by advocates of psychedelics to gain medical acceptance for the drug’s purported benefits.

The Food and Drug Administration convened a panel of outside experts on Tuesday to review the latest research on the drugwhich appears to show that it can help alleviate post-traumatic stress disorder when combined with psychotherapy.

But FDA regulators have questions about the reliability of that data, as well as about MDMA’s safety risks, which include the potential for heart problems, injuries and drug abuse.

The FDA panel will vote later Tuesday on whether to recommend the drug’s use for PTSD, which could set the stage for federal approval as soon as this summer, although the FDA is not required to follow the group’s recommendations.

MDMA, sometimes called ecstasy or molly, would become the first illegal psychedelic, if approved, to make the leap into mainstream medicine. The drug is the first in a series of psychedelics – including LSD and psilocybin – which are expected to be presented to the FDA in the coming years as part of renewed research and interest in their potential to address difficult-to-treat conditions such as depression, addiction and anxiety.

Currently, only antidepressants are FDA approved for PTSD, which is closely linked to depression, anxiety, and suicidal behavior. PTSD is also more prevalent among women and veterans.

But the FDA’s review of MDMA highlights the challenges of studying and evaluating psychedelic drugs.

“This application is consequential and complex,” FDA reviewer Dr. Tiffany R. Farchione said at the start of Tuesday’s meeting.

Because MDMA causes intense psychological experiences, nearly all patients in two major studies of the drug were able to guess whether they had received MDMA or a dummy pill. This is the opposite of the objectivity typically required for high-quality drug research, in which patients cannot tell whether they received the drug being tested.

“This makes it difficult to know how much of the treatment effect is a true benefit and how much is due to expectation bias,” Farchione said.

The FDA will ask its external panel about this question and several others, including uncertainty about how long MDMA’s benefits might last. About 25% of patients dropped out of a follow-up study designed to track long-term results.

FDA regulators are also concerned about the drug’s safety risks, including whether patients could harm themselves if they are still impaired by the drug’s effects, which can last eight hours or more. MDMA is also associated with increased blood pressure.

Because of these risks, the FDA proposed strict limits on how and where MDMA could be used, if it were approved. Only specially certified doctors and therapists could prescribe and administer the medicine. Patients would have to be registered and tracked over time. Healthcare professionals would also need to be available to measure patients’ vital signs while they take the medication.

Representatives from drugmaker Lykos Therapeutics said Tuesday they agreed with such precautions and hoped it would speed the drug’s approval.

“It is clear that MDMA-assisted therapy would be a welcome addition to currently available options,” said Dr. Kelley O’Donnell, a psychiatrist at New York University who helped lead the MDMA studies. “I have seen firsthand how this treatment can save lives for some.”

Lykos is essentially a corporate spinoff of country’s leading psychedelic advocacy group, the Multidisciplinary Association for Psychedelic Studies, or MAPS, which funded the studies. The group was founded in 1986 to promote the benefits of MDMA and other mind-altering drugs.

In the two main studies, patients received MDMA as part of an intensive four-month course of psychotherapy that lasted more than a dozen sessions, only three of which involved taking the medication. After treatment, patients who received MDMA had significantly lower PTSD scores.

MDMA acts on two well-being brain chemicals that are believed to enhance psychotherapy: serotonin and dopamine. Experts believe the medicine helps patients face past traumas, reducing fear and increasing their connection and trust with therapists.

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