American drug regulator panel will assess the psychedelic drug MDMA for the first time

A panel of advisers to the US Food and Drug Administration will meet Tuesday to discuss a therapy based on the psychedelic drug MDMA for patients with post-traumatic stress disorder (PTSD).

The meeting of the agency’s independent experts is the furthest an MDMA-based drug, commonly known as ecstasy or molly, has ever advanced in the FDA regulatory process for approval.

It is the culmination of a decades-long effort by advocates who say drugs like MDMA can treat mental disorders and have therapeutic applications beyond their illegal use.

The treatment is a capsule form of MDMA, made by public organization Lykos Therapeutics, and is intended to be administered along with talk therapy sessions by a licensed mental health provider.

In clinical trials of more than 190 patients, those given doses of MDMA in addition to therapy showed a significant reduction in PTSD scores compared to placebo.

However, FDA reviewers raised concerns Friday that patients in the studies were unaware of whether they were receiving MDMA or a placebo for the psychedelic effects, clouding the drug’s effects.

“I don’t think this is that big of a problem because even if it’s an enhanced placebo effect, people still get better,” says David Olson, director of the UC Davis Institute for Psychedelics and Neurotherapeutics.

“But the bigger question is: What is the risk to these individuals?”

PTSD affects 13 million Americans and is especially common among combat veterans. There remains a large unmet need for new treatments for PTSD as existing medications do not work in all patients.

The Lykos treatment is one of several psychedelic drugs being tested in patients with difficult-to-treat mental illnesses, such as Compass Pathways’ drug, which uses the same component as magic mushrooms.

FDA staff proposed restrictions around its use and monitoring in their briefing papers on Friday. The FDA also noted an increase in blood pressure and heart rate in the studies and liver toxicity cases.

The approval could “provide a new treatment option, but won’t make a big dent on its own,” due to the cost and complexity involved, Olson said.

“It’s important because it would be the first in this class of molecules, but I don’t think it will be the last. It will be replaced by compounds that have superior properties to MDMA.”