On Tuesday (June 4), advisers for the U.S. Food and Drug Administration (FDA) voted against MDMA (Methylenedioxymethamphetamine) therapy after previously considering the use of the drug to treat PTSD (Post-Traumatic Stress Disorder).
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For the first time ever, FDA advisers were considering whether to recommend MDMA, commonly known as party drugs ecstasy or molly, for approval as a new way to treat PTSD. Although, it would be a pharmaceutical version of MDMA which has been developed by Lykos Therapeutics and is called Midomafetamine.
Those who argued for the pharma-brand MDMA said it had the potential to transform a field with significant need, however, the committee had concerns about the integrity of the two controlled trials presented to them (which showed participants using MDMA for treatment in addition to therapy).
Ahead of the FDA panel’s historic consideration of the treatment, Lykos Therapeutics CEO Amy Emerson released a statement that in part read, “This will be the first MDMA-assisted therapy and psychedelic-assisted therapy to be reviewed by the Psychopharmacologic Drugs Advisory Committee, a significant milestone in the field of psychedelic medicine, resulting from decades of clinical research and advocacy.”
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On Tuesday, a federal advisory committee gathered and voted overwhelmingly against the psychedelic drug for medical use. Two of the 11 committee members deemed the treatment effective, while nine felt the opposite. One of the two who voted for the treatment insisted that the benefits of the treatment outweighed the risks as presented.
In the FDA briefing documents, released on Friday (May 31), Lykos Therapeutics revealed that during their clinical trials “participants appear to experience rapid, clinically meaningful, durable improvement in their PTSD symptoms.” However, some of the concerns include the fact that the drug is known to cause impairment, which could become a greater risk for the user.
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Before the Tuesday decision, the FDA, which had until August 11 to respond, said that if the drug gets approved, safeguards would have to be put into place for a future clinical trial, in which participants would be monitored by two therapists over of period of 8 hours and would not be permitted to drive until the following day.
MDMA is known as an entactogen, a class of psychoactive drugs that produce experiences of emotional communion, relatedness, and emotional openness; and it’s currently classified as a Schedule I drug under the Controlled Substances Act.
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