Medmonitor

The FDA declined to approve a new drug application for MDMA as a treatment for PTSD. The FDA cited insufficient data, requesting additional clinical trial data to assess safe and effective use. The initial application presented positive data from two late-stage clinical trials that used MDMA in combination with talk therapy to treat PTSD, the FDA noted that participants appeared to experience rapid and clinically meaningful, durable improvement in their PTSD symptoms. However, the FDA considered the trial data on efficacy of MDMA to be blurry and had concerns about safety data. The drug sponsor of the MDMA trial, Lykos, has stated they will work diligently to address the FDA concerns and supporters of MDMA as PTSD treatment are confident it will eventually be approved.

The FDA issued a warning regarding the use of compounded ketamine products for the treatment of psychiatric disorders. Ketamine is not FDA-approved for the treatment of any psychiatric disorder. It is important to note that ketamine is a mixture of two mirror-image molecules, and in 2019, the FDA did approve Spravato (esketatmine) CIII nasal spray for treatment-resistant depression in adults and for depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior (in conjunction with an oral antidepressant). Spravato only includes the esketamine molecule and is a Schedule III controlled substance with an associated Risk Evaluation and Mitigation Strategy (REMS) program due to risks of serious adverse outcomes from sedation, dissociation, and abuse and misuse. This new warning from the FDA speaks to compounded ketamine products used without monitoring by a healthcare provider, as they come with risks for sedation, dissociation, and changes in vital signs, which may put patients at risk for serious adverse events.