A panel of advisers to the U.S. Food and Drug Administration were set to vote on Tuesday on whether a therapy based on psychedelic drug MDMA should be recommended for patients with post-traumatic stress disorder.
The meeting by the agency’s independent experts, currently underway, is the farthest a drug based on MDMA, commonly known as ecstasy or molly, has ever reached in a FDA regulatory process for approval.
It follows a decades-long push by advocates who say drugs such as MDMA can treat mental health disorders and have therapeutic applications beyond their illicit use.
The treatment, a capsule form of MDMA made by public-benefit corporation Lykos Therapeutics, is intended to be administered to patients in combination with talk therapy sessions by a licensed mental health provider.
Over 190 patients, who received doses of MDMA in addition to therapy, showed a significant reduction in PTSD scores compared to placebo.
The FDA’s staff reviewers on Friday raised concerns that patients in the trials were aware of whether they were given MDMA or a placebo due to its psychedelic effects, preventing an objective view on how well the drug worked.
The FDA, during the panel meeting, said there was a “striking lack” of documentation of abuse related adverse events, which may limit the agency’s ability to explain the effects of MDMA or determine its abuse liability.
The panel is expected to issue its non-binding recommendation on the therapy’s effectiveness, and whether its benefits outweigh the risks associated with the treatment after 1555 ET.
Scrutiny into Lykos’ drug has increased in recent months after an influential non-profit, the Institute for Clinical and Economic Review (ICER), said there was “insufficient” evidence for the benefits of MDMA-based therapy.
In a letter dated Monday, the American Psychological Association echoed those comments, saying its panel of experts were unable to determine the balance of benefits and potential harms.
PTSD affects 13 million Americans and is especially common among war veterans. There is a large unmet need for new treatments for PTSD as existing drugs do not work on all patients.
The FDA’s staff on Friday proposed restrictions around Lykos’ drug and a need to monitor its usage in briefing documents. The staff also flagged a rise in blood pressure and pulse in the trials, and in cases of liver toxicity.