In late August, the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to methylenedioxymethamphetamine (MDMA) for the potential treatment of post-traumatic stress disorder (PTSD). MDMA is the primary ingredient for the recreational drug more commonly known as ecstasy.
The medical use of MDMA is highly controversial. MAPS has been supporting MDMA research for several decades. The non-profit and the FDA have reached an agreement on the design and endpoints of two Phase 3 trials using MDMA-assisted psychotherapy to treat adult patients with PTSD. The first trial will open enrollment in Spring of 2018.
PTSD and workers’ comp
In some states, PTSD is compensable as a primary condition under workers’ compensation for certain high-stress occupations, such as first responders. In other cases, PTSD may also develop as a secondary mental condition as a result of traumatic injury. Several states are in the middle of deliberating if, and to what degree, PTSD should be covered under workers’ compensation.
About Breakthrough Therapies
The FDA grants Breakthrough Therapy Designation to treatments that (1) are intended alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition; and (2) preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug. For more information, see the FDA's Fact Sheet.
Read the full press release from MAPS here.