FDA grants expanded access to MDMA to explore drug’s impact on PTSD sufferers

Last updated: 28 ม.ค. 2563  | 

PUBLISHED : 28 JAN  2020 - 15:41

MDMA, commonly called ecstasy, is on the way. It’s just going to take some time. The Multidisciplinary Association for Psychedelic Studies (MAPS) noted that the U.S. Food and Drug Administration (FDA) has approved its request to grant expanded access to the psychedelic drug more commonly associated with music festivals and raves than doctors’ offices.

The designation allows for the implementation of new therapies for patients suffering from post-traumatic stress disorder (PTSD) who have not responded to currently available treatment methods, according to Merry Jane.

“We commend (the) FDA for recognizing the great unmet medical need of PTSD by allowing access to MDMA-assisted psychotherapy on a compassionate basis for people with treatment-resistant PTSD,” said Rick Doblin, founder of MAPS. “We are delighted to begin generating real-world evidence about this potential new treatment.”

MAPS is also currently conducting Phase 3 clinical trials on MDMA, but the newly approved program deals specifically with treatment-resistant strains of PTSD. For comparison, the FDA has still not allowed Phase 1 clinical trials to be conducted into marijuana flower despite the drug being legal in some form in over half of the U.S.

Access to the program will be extremely limited, with just 50 patients initially eligible to receive MDMA-assisted treatment before the FDA makes a ruling on expanding the program. Patients will be required to prove they have a treatment-resistant version of PTSD and will have to foot the bill for a place in the program, which is expected to cost in the neighbourhood of US$15,000.

“The resurgence of research into using drugs such as MDMA to catalyze psychotherapy is the most promising and exciting development I’ve seen in my psychiatric career,” said Michael Mithoefer, acting medical director for MAPS’s Public Benefit Corporation.

Research is slowly building that MDMA, psilocybin and other hallucinogenics are capable of increasing empathy and decreasing the symptoms of trauma in humans. A recent study concluded that MDMA could assist women suffering from PTSD caused by sexual trauma. Across the board, patients who have received a higher dosage of MDMA experienced greater reduction in symptoms, sometimes lasting years after exposure to the drug concluded.

“Combining the powerful effects of pharmacology with the potential depth of psychotherapy is a compelling model for harnessing advances in neuroscience and psychopharmacology without ignoring the complexity, richness and innate capacity of the human psyche,” Mithoefer said.

Want to keep up to date on what’s happening in the world of cannabis? Subscribe to the Cannabis Post newsletter for weekly insights into the industry, what insiders will be talking about and content from across the Postmedia Network.

Source: https://www.thegrowthop.com/cannabis-health/fda-grants-expanded-access-to-mdma-to-explore-drugs-impact-on-ptsd-sufferers