In the United States, a group of lawmakers has again pressed the FDA to approve MDMA, more commonly known as ecstasy or molly, to treat post-traumatic stress disorder, according to Becker’s Behavioral Health.
The 61 representatives sent a letter to President Joe Biden on Aug. 2 calling for action on “the serious need for new and better treatment options” for PTSD.
In June, an FDA advisory panel voted 9-2 to recommend that MDMA, or midomafetamine, in combination with psychotherapy is not effective in treating PTSD, and 10-1 that the risks of the therapy outweigh the benefits. The advisory panel expressed concerns about the validity of the drug’s clinical trials.
Jack Bergman, the lawmaker leading the effort to convince the FDA to approve the drug, told political lawmakers that they lean “gently but positively” on the FDA.
“The strategy here is to put pressure in a positive way so that the bureaucracy feels it’s OK to assume some risk,” Bergman said.
In the letter, the lawmakers wrote that while criticism of the treatment “may be well-intentioned, their criticism is not necessarily reflective of the science, but rather their personal ideological beliefs and biases related to the medicalization of substances like MDMA.”
Lykos Therapeutics, the company that developed the treatment, released a statement saying it would implement additional oversight if it was approved by the FDA, as well as create an independent advisory board to inform the drug’s commercial launch potential.
FDA must communicate the final decision on the drug by August 11. If approved, it would be the first new treatment for PTSD in 25 years.