FDA committee gives thumbs down to MDMA for PTSD
June 19, 2024
A Food and Drug Administration (FDA) advisory committee just recommended against approval of MDMA (3,4-Methylenedioxymethamphetamine, also known as Ecstasy) to treat post traumatic stress disorder (PTSD). The committee voted 9-2 that there was not adequate evidence of effectiveness. The FDA is not obligated to follow this recommendation. Lykos Therapeutics, the manufacturer, will likely need to repeat some of its research.
Lykos is seeking approval for the combination of the drug MDMA and a course of psychotherapy, and tested MDMA + psychotherapy compared to placebo + psychotherapy. The results look good on the surface; those treated with MDMA were 32% more likely to respond to therapy, 70% more likely to achieve resolution of PTSD, and 186% more likely to have remission of PTSD. But the Institute for Clinical Effectiveness Research (ICER) issued a report this spring that questioned the validity of some of Lykos’ research. All of those given active medication recognized that they were not on placebo, meaning that the trial was not “blinded.” Further, the company did not track some of the outcome measures requested by the FDA.
This is disappointing.
PTSD affects about 6% of adults at some point, and as many as 5% of adults in any given year in the US. Those with PTSD are generally treated with psychotherapy often augmented with antidepressants, but many need long-term therapy, and PTSD is a major cause of disability.
Still, there are many psychedelics in the pipeline for PTSD, as well as depression, and it’s likely that additional psychedelic drugs will be approved over the coming years. Australia legalized MDMA for PTSD in 2023, so more data may be forthcoming to inform the US process in the future. A few US states have legalized psilocybin, psychedelic mushrooms, for individual use, but standardized pharmaceutical grade medications from this mushroom are not currently available.
Implications for employers:
Treatment-resistant depression and PTSD are both common and clinically difficult to treat.
Psychedelics can play an important role, and the FDA will be evaluating other drugs in the coming months.
Many providers are using generic ketamine, an anesthetic with psychedelic properties, off-label for patients with treatment resistant depression. There are two third-party administrators, Enthea and Taramind, that are currently marketing their networks and psychedelic coverage to employers.
Esketamine (Spravato) is a derivative of ketamine available in a nasal spray FDA approved for drug-resistant depression. It is expensive and requires observed administration. It is available on some PBM formularies. No other psychedelics are FDA approved at this time.
Thanks for reading. You can find previous posts in the Employer Coverage archive
Please subscribe, “like” and suggest this newsletter to friends and colleagues. Thanks!
Illustration by Dall-E
Tomorrow: Thursday shorts and follow ups