PTSD is a big problem worldwide. In America alone, the suicide rates have been on the rise, increasing by 33% since 1999. On top of that, over 800,000 veterans are on disability pay receiving checks from the government due to PTSD. The situation is not only devastating and debilitating for the individuals, but it is costing taxpayers an estimated $17 billion per year. This is why the government allowed a treatment center to try something new – to treat patients with MDMA.
A clinic in Pennsylvania may become the first legally-sanctioned dedicated facility for using the psychoactive drug on treatment-resistant PTSD in the United States after clinical trial testing was a grand success. MDMA is now being recognized as a serious prospective cure for emotional trauma.
The new clinic called Landing is based in Wyndmoor, Montgomery County and was founded by Dr. Samy Badawy. It hopes to secure FDA approval in the months ahead enabling it to offer MDMA-assisted psychotherapy for patients with treatment-resistant PTSD. If it does, it will specialize in using several psychoactive drugs to treat a variety of mental health disorders.
MDMA And The FDA
MDMA has been illegal since 1985 due to its popularity as a party drug. However, as many people with PTSD were having problems recovering, the FDA overlooked that fact and granted the substance a “breakthrough therapy” designation in 2017 after several studies proved its surprising success in treating PTSD. Specifically, it was a study published by the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) which showed very promising results of six phase-2 clinical trials of MDMA-assisted psychotherapy, that earned Landing FDA authorization to continue.
The Studies
- 107 participants with chronic, treatment-resistant PTSD were enrolled to receive therapy.
- The therapy involved several sessions over the course of one month.
- After two months, 56% of the patients no longer showed symptoms that qualified as PTSD.
- After 12-months they did a follow-up and 68% “no longer had PTSD.”
The study results were hailed as a groundbreaking achievement since scientists have not been able to find any new drug treatments for PTSD in 17 years. “[It] was astonishing,” Sue Sisley, physician, and president of the Scottsdale Research Institute told NPR. “Even with the best pharmaceutical regimen, you rarely ever see patients go into remission.”
Another study that helped illustrate the effectiveness of the drug was conducted by researchers from Johns Hopkins University. They found that MDMA triggers a neural response called a “critical period” during which the brain is sensitive to learning the reward value of social behaviors. Meaning, patients can use this critical period to revisit traumatic events in a clinical setting so that they can form positive associations with negative memories. MAPS has been sponsoring phase-3 clinical trials for this psychoactive treatment at more than a dozen clinics in Canada, Israel, and the US and they are optimistic that the drug will be approved by FDA and ready for use as early as 2021.
Expanded Access
The Landing is pushing for the FDA to grant the drug “expanded access”—a designation which allows a patient with an “immediately life-threatening condition, serious disease, or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.” If approved, the clinic could even start offering the treatment to patients by early 2020.
