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FDA Designating Ecstasy as Treatment for PTSD

Image: FDA Designating Ecstasy as Treatment for PTSD
(AP Photo/Peter Byrne)

By    |   Wednesday, 30 Aug 2017 03:55 PM

Ecstasy has been designated by the Food and Drug Administration as a "breakthrough therapy" to treat post-traumatic stress disorder, Stars and Stripes reported.

The move provides a fast-track for approval for MDMA, as the controversial party drug is officially known, as a prescription drug — the result of trials that have included military veterans since 2010, the news outlet reported.

"It doesn't mean anything is approved or guaranteed, but it does mean this gets special attention from the FDA and allows it to move through the regulatory process more quickly," Michael Mithoefer, a clinical investigator who is involved in the study of MDMA-assisted psychotherapy, told Stars and Stripes.

The Department of Veterans Affairs in 2014 issued guidance on therapy, not medication, as a treatment for PTSD. Milhoefer told Stars and Stripes MDMA makes that therapy more effective.

Mithoefer said the street drug "seems to help people face the trauma without being overwhelmed by anxiety."

The Multidisciplinary Association for Psychedelic Studies has sponsored trials on Ecstasy for PTSD treatment, with a Phase 3 trial expected to start in 2018 involving more than 200 participants at sites in the United States, Canada and Israel, the outlet reported.

MAPS aims to have MDMA approved as a prescription medication by 2021, Stars and Stripes reported.

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Ecstasy has been designated by the Food and Drug Administration as a "breakthrough therapy" to treat post-traumatic stress disorder, Stars and Stripes reported.
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2017-55-30
Wednesday, 30 Aug 2017 03:55 PM
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