Sriparna Roy and Pratik Jain
(Reuters) – A panel of advisers to the U.S. Food and Drug Administration will meet on 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 the MDMA-based drug, commonly known as ecstasy or molly, has ever gone in the FDA approval process.
It follows years of efforts by advocates who argue that drugs like MDMA can treat mental disorders and have therapeutic uses beyond their illicit use.
The treatment is a capsule form of MDMA manufactured by Lykos Therapeutics, a public benefit corporation, and is intended to be used in conjunction with talk therapy sessions by a licensed mental health provider.
In clinical studies involving more than 190 patients, those who received doses of MDMA in addition to therapy showed significant reductions in PTSD scores compared to placebo.
But on Friday, FDA reviewers expressed concern that patients in the trials knew whether they were given MDMA or a placebo for its psychedelic effects, clouding the drug’s effectiveness.
“I don’t think it’s that much of a concern because even if it’s an enhanced placebo effect, people still get better,” said David Olson, director of the Institute for Psychedelics and Neurotherapeutics at the University of California, Davis.
“But the more important question is, what is the risk to these people?”
PTSD affects 13 million Americans and is especially common among military veterans. There remains a large unmet need for new treatments for PTSD because existing medications do not work for all patients.
The Lykos treatment is one of several psychedelic drugs being tested on patients with difficult-to-treat mental disorders, such as the drug Compass Pathways, which uses the same ingredient as magic mushrooms.
FDA staff proposed restrictions on its use and monitoring in its briefing documents Friday. The FDA also noted increases in blood pressure and heart rate during trials and liver toxicity cases.
The approval may offer “a new treatment path, but on its own will not have much impact” because of the costs and complexities involved, Olson said.
“This is important because it will be the first molecule in this class, but I don’t think it will be the last, it will be replaced by compounds that have superior properties to MDMA.”