More than 700 veterans and 80 lawmakers are calling on the top official for the Food and Drug Administration to approve the first-ever psychedelic drug treatment for post-traumatic stress disorder. An FDA decision is expected this month. (Department of Defense)
WASHINGTON — More than 700 veterans and 80 lawmakers are calling on the top official for the Food and Drug Administration to approve MDMA-assisted therapy as the first-ever psychedelic drug treatment for post-traumatic stress disorder.
MDMA, commonly known as ecstasy, is a Schedule 1 drug that is illegal.
Two separate letters signed by 61 House members and 19 senators were sent Monday to Dr. Robert Califf, the FDA commissioner, requesting the agency approve the psychedelic-assisted therapy for treating PTSD, a psychiatric disorder that afflicts individuals who have experienced trauma. The FDA is scheduled to decide on the drug treatment by Aug. 11.
A third letter was also sent Monday signed by more than 700 veterans, first responders and veterans advocacy groups.
The organizations included Heroic Hearts Project, Healing Breakthrough and Veterans Exploring Treatment Solutions. All have missions that support psychedelic therapies for veterans suffering from PTSD, military sexual trauma, traumatic brain injuries and other mental health problems from military service.
The letters advocate for the clinically supervised use of MDMA in therapy to ease the anxiety, negative thinking and depression that people with PTSD often experience.
“Given the substantial burden of PTSD and the current treatment limitations, the possibility of new, more effective therapies is particularly meaningful,” according to the letter from senators, which was led by Sens. Michael Bennett, D-Colo., and Thom Tillis, R-N.C. “One such promising therapy under consideration is MDMA-assisted therapy.”
“The FDA should remain firmly anchored in scientific evidence and data when evaluating new treatments. The potential for groundbreaking advancements in PTSD treatment is within reach, and we owe it to our veterans and other affected populations to review these potentially transformative therapies based on robust clinical and scientific evidence,” the senators’ letter concludes.
A clinical dose of MDMA, a psychedelic drug commonly known as ecstasy, is shown here. (Multidisciplinary Association for Psychedelic Studies)
The FDA has not approved a new treatment for PTSD is more than 20 years. Many veterans now travel outside the U.S. to receive psychedelic-assisted therapy.
Though 5% of the general population suffers from PTSD, 10% of male veterans and 19% of female veterans are diagnosed with PTSD annually, according to the Department of Veterans Affairs. PTSD is considered a risk factor in veteran suicides.
Ecstasy increases serotonin levels in the brain, according to Lykos Therapeutics, a nonprofit pharmaceutical company that has a proposal before the FDA to develop and market MDMA for prescription use in clinical settings.
The drug would be administered as a pill in conjunction with 42 hours of talk therapy, according to the Lykos proposal before the FDA.
Ecstasy was designated as a breakthrough therapy by the FDA in 2017, which authorized the agency to work with the drug maker on designing clinical trials for research into the drug’s effectiveness and safety.
“Promising new treatments like MDMA-assisted therapy have the clinically proven potential to bring veterans who have long suffered with PTSD a treatment that works,” according to the letter signed by House members.
The third letter stated FDA approval for MDMA-assisted therapy will ensure that veterans can “safely and equitably” access the treatment.
Rep. Morgan Luttrell, R-Texas, a former Navy SEAL, has discussed his experience with psychedelic-assisted therapy that he received in Mexico following military service.
He said he suffered from the effects of traumatic-brain injuries and credits the therapy with improving his mental health and saving his marriage.
“I can honestly stand in front of all of you and the American public and say I was reborn,” Luttrell has said previously. “The effects of emerging therapies for our veterans have been groundbreaking, and I’m proud to be a leader on pushing forward this innovative tool into the proverbial toolbox.”
