Summary: Breitbart reports on the FDA’s agreement to MAPS’ application for an Expanded Access program with MDMA-assisted psychotherapy for PTSD, explaining that “MDMA-assisted psychotherapy will soon be available to patients outside of research and clinical trials.”
Originally appearing here.
The Food and Drug Administration (FDA) has granted expanded access for treatments employing the drug commonly known as “ecstasy,” or MDMA.
The Multidisciplinary Association for Psychedelic Studies (MAPS) announced Friday that the FDA has expanded access to the drug for use in treatment, so MDMA-assisted psychotherapy will soon be available to patients outside of research and clinical trials.
This “compassionate use” expansion has already approved 50 new patients — at ten as-yet-unannounced sites across the country — for the innovative new method of psychotherapy. Already, a further 120 sites have applied for use of the treatment.
Phase three clinical trials remain underway, on sites in the United States, Canada, and Israel. MAPS expects these trials to be completed in 2021, and the FDA could fully approve the treatment as soon as 2022. It could represent a life-changing opportunity for those who have struggled with severe Post-Traumatic Stress Disorder (PTSD). Studies shown so far offer a lot of hope, especially to our military veteran population.
While roughly eight percent of the U.S. population suffers from some form of PTSD, veterans experience it at a significantly higher 11-20 percent. Iraq War veteran Jonathan Lubecky is among the most inspirational stories of MDMA-assisted psychotherapy’s potential.
Sergeant Lubecky was deployed to Balad Air Base in 2006, during the Iraq War. In one of the numerous mortar strikes the soldiers endured, Lubecky suffered a traumatic brain injury. Despite a multitude of treatments, Lubecky attempted suicide on five separate occasions.
“I already had five suicide attempts. I put a gun to my head twice and pulled the trigger,” Lubecky told Stars and Stripes. “I figured I was going to die anyway, that I might as well try ecstasy. And then it worked.”
“The MDMA puts the mind, body and spirit in a place it needs to be in order to heal,” he said. “It’s like doing therapy while being hugged by everyone who loves you in a bathtub full of puppies licking your face. That’s the best way I’ve been able to describe it.”
His verdict on the treatment could not be more clear: “I’d be in Arlington cemetery,” he said. “The biggest impact on this has been my stepson. It’s the reason he has a father instead of a folded flag.”