FDA approves large-scale trial of MDMA to treat PTSD

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WASHINGTON — The Food and Drug Administration has approved a large-scale clinical trial of the drug MDMA — the final step before possible approval for use as a prescription drug, the New York Times reports.

The feel-good party drug is sometimes referred to as ecstasy or molly. However, according to The Drug Policy Alliance, anything sold as molly or ecstasy could range from being pure MDMA, to being cut with other drugs, to containing no MDMA at all.

“The researchers are so optimistic that they have applied for so-called breakthrough therapy status with the Food and Drug Administration, which would speed the approval process,” The Times reported. “If approved, the drug could be available by 2021.”

A leading post-traumatic stress disorder researcher who was not involved in the study told The Times that he is hopeful but also has some concerns.

“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,” Dr. Charles R. Marmar, the head of psychiatry at New York University’s Langone School of Medicine, was quoted as saying.

Marmar said he is also concerned about the potential for abuse and the effects of long-term use.

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

However, The Times said the drug would be administered “a limited number of times” and pointed to a previous study that showed 56 percent of patients showed an improvement after three doses.

The study also pointed out an “absence of harmful effects or drug dependency.”

The Times said a spokesman for the FDA declined a request for a comment, citing regulations that prohibit disclosing information about drugs that are being developed.