With a June 4 FDA advisory committee meeting looming, the Institute for Clinical and Economic Review has raised concerns about Lykos Therapeutics’ trials of its MDMA-assisted therapy in post-traumatic stress disorder.
Due to concerns of study bias, the Institute for Clinical and Economic Review on Tuesday said in a draft report that it is unable to accurately assess the net benefit of Lykos Therapeutics’ investigational MDMA-assisted therapy in post-traumatic stress disorder.
The drug price watchdog said that investigators, study therapists and patients held “very strong prior beliefs” about MDMA, which could have affected the recording of harms and benefits of the investigational treatment. The trial therapists and some of its participants were “pulled heavily” from a community interested in the use of psychedelics for psychological benefits, according to the Institute for Clinical and Economic Review (ICER) draft report.
These sentiments about psychedelics “lead the community to engage with them more like a religious movement than pharmaceutical products,” ICER’s draft report concluded, noting that these feelings were not only common among participants but were also sometimes “inculcated in patients participating in the trials.”
ICER said it also had been informed of “pressures” to keep the result of Lykos’ trials “favorable.” Some participants felt that they were pushed to report only the good outcomes while suppressing bad results. ICER cited first-hand and second-hand accounts of “extremely severe negative outcomes” which some trial therapists said were proof of appropriate treatment response.
“Some patients were prevented from entering the long-term follow-up study and felt this was done to keep these negative outcomes out of the data set,” according to ICER.
The watchdog also pointed out that Lykos’ trials were “essentially, unblinded” because the psychedelic effects of MDMA allowed the patients to determine if they were given the active treatment or the control. The MDMA treatment was correctly identified by “nearly all patients” who received it.
In response to ICER’s findings, Lykos said in a public comment folio that it was “disappointed” by the draft report, noting that the watchdog “discounts the significant unmet medical need for patients living with” post-traumatic stress disorder (PTSD).
ICER “relies on a limited number of stakeholder perspectives, and focuses on areas squarely within the FDA’s purview on the evaluation of safety and efficacy of drugs,” according to Lykos.
ICER’s draft report comes as Lykos gears up for an FDA Psychopharmacologic Drugs Advisory Committee meeting set for June 4, 2024. The panel of external experts will discuss Lykos’ application to use the psychedelic compound MDMA as a treatment for adults with PTSD, when used in conjunction with psychotherapy and other supportive mental health interventions.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
