MDMA trials get FDA backing for PTSD treatment

pharmafile | November 30, 2016 | News story | Research and Development FDA, MDMA, PTSD 

The FDA have given the go-ahead to Phase 3 clinical trials investigating the efficacy of MDMA (Methylenedioxymethamphetamine) for treating post-traumatic stress disorder (PTSD), a promising step on the road for the traditionally recreational drug to become a prescribed therapy.

The drug has shown promising data in treating PTSD and terminal illness: in initial studies, alongside 12 weeks of psychotherapy, patients were administered with MDMA in three eight-hour sessions where they sat in a safe and relaxing environment, surrounded by candles, flowers and soothing music.

Researchers observed a 56% decrease in symptom severity following the treatment, with two out of three patients falling below the defining criteria for PTSD  by the study’s end. Follow-up studies found that these results lasted up to a year longer than conventional treatments.

The studies were funded by the Multidisciplinary Association for Psychadelic Studies (MAPS), an advocate of psychedelic drug use as a clinical therapy since 1985. The association assisted six Phase 2 trials and will contribute towards the 230-participant Phase 3 trial.

These studies could help to reveal the benefits of MDMA as an alternative treatment for those who have not responded to other forms of therapy. Discussing the findings, principal investigator Dr Ingrid Pacey explained:

“The biggest thing was there was a very increased level of trust. They were really able to talk about painful material from the past that they were never able talk about before in their life — they’d been so frightened they’d block it. With the MDMA, they’d be distressed and crying, but they could talk it through and come to understand it in a way they couldn’t before. The trauma became a more manageable part of their history and they could go forward with their lives.”

PTSD researcher Dr Charles R. Marmar, the head of psychiatry at New York University’s Langone School of Medicine, said the results were promising, but there is still more work to be done.

“I’m cautious but hopeful. If they can keep getting good results, it will be of great use. PTSD can be very hard to treat. Our best therapies right now don’t help 30 to 40 percent of people. So we need more options.”

However, critics are quick to point out that legitimate prescription of MDMA as a clinically-approved therapy could lead to a rise in illicit acquisition of the drug as sufferers seek to self-medicate, in a manner similar to the recent increase in abuse of opioids.

“It’s a feel-good drug, and we know people are prone to abuse it,” Marmar added. “Prolonged use can lead to serious damage to the brain.”

The researchers of the study have applied for breakthrough therapy status with the FDA, which means that, if approved, the drug could be available as soon as 2021.

Matt Fellows

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