The staff of the United States Food and Drug Administration published briefing documents that raised concerns about the risks of Lykos Therapeutics Inc. drug MDMA, whose objective is to treat a form of mental illness.
“Several factors make these data difficult to interpret and complicate the risk-benefit assessment for this application,” agency staff said in documents posted on its website.
The documents were released ahead of a meeting scheduled for next week where FDA advisers will discuss the drug for treating post-traumatic stress disorder. If approved, Lykos’ drug would become the first new drug for post-traumatic stress disorder in two decades. The elimination of the psychedelic drug, more commonly known as ecstasy or molly, could help boost recreational drugs into mainstream medical applications.
The expert panel, called the Psychopharmacological Drugs Advisory Committee, will evaluate the data and hear presentations from the company and health officials. The agency is not required to follow the guidance of its advisors, but it usually does.
In his report, FDA staff cited difficulties in evaluating both the risks and benefits of the drug, which can increase the risk of cardiac events by increasing patients’ pulse and blood pressure. They also cited the vulnerability of patients under the influence of the drug.
“We are particularly concerned that serious harm may occur while patients are affected,” FDA staff said in their report. “Serious harm due to patient deterioration may include, but is not limited to, events that result in hospitalization or death, events that put patients at risk of hospitalization or death, and events with significant negative consequences.”
Post-traumatic stress disorder It often develops after patients witness or experience a traumatic or life-threatening event. About 6% of the US population has had post-traumatic stress disorder at some point in their lives., according to the United States Department of Veterans Affairs, although it is more likely to occur in women and veterans who have experienced events such as sexual assault or military combat. The VA, which cares for a large population of PTSD patients in the nation’s largest health system, has said psychedelic drugs have “significant potential.”
However, an independent scientific group that evaluates the treatments and their prices has raised worrying questions about the research behind MDMA in post-traumatic stress disorder. One of the criticisms raised by the group, called Institute for Clinical and Economic Review, is that most participants were able to determine whether they were receiving the drug or a placebo. Subjects may have been encouraged to report good results and suppress bad ones, ICER said in a report.
The non-profit organization behind Lykos, The Multidisciplinary Association for Psychedelic Studies, or MAPS, has been researching psychedelic therapies for more than three decades and participated in almost all of the major studies on MDMA for PTSD. That contributed to accusations that its close-knit culture has created an atmosphere in which negative reports about the drug were downplayed.
The Lykos medication is taken along with 42 hours of talk therapy, including three one-day sessions during which patients are under the influence of the medication. The combination treatment improved PTSD symptoms in most patients, according to findings from two late-stage trials. Two-thirds of patients who received the drug no longer had a diagnosis of PTSD about two months later, compared with less than half of participants who showed improvement with talk therapy alone.
