Following the September 6, 2024 public meeting hosted by the Reagan-Udall Foundation for the FDA in which agency officials joined representatives from the Department of Defense (DoD) and VA, patients, advocates, and industry representatives to discuss the current treatment landscape and what can be done to accelerate development of PTSD treatment, Reason for Hope and VMHLC have provided comments on advancing treatment for PTSD.
"Recent trials with novel therapies like MDMA, psilocybin, and other psychedelic compounds have demonstrated promising results suggesting they can be effective treatments for PTSD and a variety of related mental health conditions. Thus, it is critical that FDA finalize its June 2023 draft guidance on psychedelic drug development, and that it adheres to its guidance, or provides timely advice to sponsors on the need for any changes to a development program."