FDA Moves One Step Closer to Approving MDMA for PTSD Treatment

Northville, MI (Law Firm Newswire) October 5, 2017 – The illegal street drug MDMA, popularly known as Ecstasy to partygoers, has shown promise as a treatment for post-traumatic stress disorder (PTSD).

The U.S. Food and Drug Administration (FDA) granted the drug a “breakthrough therapy designation” following years of research into its medical uses. The designation could fast-track MDMA’s approval as a prescription medication.

The Multidisciplinary Association for Psychedelic Studies (MAPS) has sponsored research into the drug for around 30 years. Their recent clinical trials involved veterans and other participants taking MDMA doses and being guided by clinicians through intensive psychotherapy.

“While MDMA seems to offer hope for a new form of relief for individuals with PTSD, it is important to conduct thorough research before it is considered safe for veterans and others to use,” commented Jim Fausone, a Michigan veterans attorney. “Most medications tend to have some form of side effects. With MDMA, the question is whether its benefits in treating PTSD outweigh the risks.”

The Multidisciplinary Association for Psychedelic Studies conducted Phase 2 clinical trials with individuals who had chronic PTSD that was resistant to traditional treatment methods. After undergoing MDMA-assisted psychotherapy, around 61 percent of participants no longer matched the diagnosis criteria for PTSD.

According to Michael Mithoefer, a clinical researcher who is studying MDMA-assisted psychotherapy, MDMA enhances the effectiveness of traditional PTSD therapy. The drug is known to create feelings of empathy and euphoria. However, official MDMA-assisted psychotherapy is distinctly different from recreational use. The former consists of the drug being administered three times in conjunction with known psychotherapy techniques.

“So the idea with MDMA is, it seems to help people face the trauma without being overwhelmed by anxiety. It helps them to look clearly at what’s happened and their feelings with it, rather than having to avoid it as much,” said Mithoefer. Mithoefer emphasized that the aim was to target the root of the PTSD rather than simply treating the symptoms.

The FDA and MAPS will collaborate to conduct Phase 3 clinical trials for MDMA-assisted psychotherapy. The trials are scheduled to begin in 2018. MAPS is hoping to have MDMA approved as a prescription medication as soon as 2021.

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