Reuters/Paulo Whitaker

This Drug Could Actually Get Approved By The FDA For Medicinal Purposes

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A nonprofit group will reportedly seek FDA approval for medicinal MDMA following the conclusion of the last part of its study.

For several years, the Multidisciplinary Association for Psychedelic Studies (MAPS) conducted trials to determine the ability of MDMA, otherwise known as Molly, to combat post-traumatic stress disorder (PTSD).

The organization is looking to meet with the FDA to discuss the final phase of the study, which will reportedly begin next year and could lead to widespread MDMA-assisted psychotherapy.

Brad Burge, MAPS' director of communications, talked to Inverse about who will be involved in this study, as well as the success achieved so far.

The second phase of the study treated 236 people with PTSD such as veterans and survivors of sexual assault, as well as police officers and firefighters who responded to 9/11, Burge said.

The study found MDMA allows PTSD patients to "become more aware" of the physical reactions to their illness and get to "the root of their trauma," Burge said.

This could be attributed to MDMA's ability to reduce hyperactivity in the amygdala, the part of the brain associated with the fight-or-flight response.

Burge explained the MDMA helped patients better control themselves in therapy sessions, allowing them to remain calm while talking about their traumatic experiences.

Burge added,

It really only takes two to three sessions to achieve a significant reduction in their PTSD symptoms to the point where, even years later, people still aren't exhibiting symptoms.

Negative side effects were incredibly sparse, with just one patient exhibiting an elevated heart rate throughout all of the study's second phase. That patient, a 50-year-old male, did not even require treatment before being released the same day.

Patients tended to become nervous or anxious during sessions, but as Burge pointed out, that is expected because "that's the drug bringing out the effects of PTSD."

Approximately 200 to 400 patients from around the world will participate in the third phase.

This study will apparently take four to five years to complete and likely conclude with an application for FDA approval in 2021.

Aside from undeniable clinical data, MAPS may also base its case on the tremendous failure of current PTSD anti-depressants. According to Burge, symptoms are yet to decrease for up to a third of PTSD patients who have taken such medication for years.

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Citations: MDMA Steps Closer to FDA Approval as a Drug, but Now it Needs to Leap (Inverse)