Reports Say MDMA Could Get FDA Consideration for Approval Next Year

New research has found that patients suffering from moderate to severe PTSD may experience a reduction in their symptoms following treatment with MDMA. The study, which was sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), published its findings in the “Nature” journal.

Rick Doblin, president and founder of Multidisciplinary Association for Psychedelic Studies (MAPS), believes that MDMA-assisted therapy is on course for approval by the Food and Drug Administration (FDA) in 2024, thanks to the efforts of many therapists, participants and donors.

The study, which involved a randomized, placebo-controlled, double-blinded trial, recruited 104 individuals with PTSD who received either a placebo or MDMA then underwent talk therapy by qualified therapists. The trial determined that MDMA significantly reduced PTSD symptoms in comparison to the placebo. The findings add to growing literature showing that MDMA could be a game-changer, especially for the many patients who gain no benefit from currently prescribed drugs and therapies.

In their report, the researchers stated that MDMA improved therapy by breaking down boundaries that could hinder patients from processing trauma from their past. They also explained that the drug softened responses to fearful and emotionally challenging stimuli while also producing prosocial feelings that possibly improved patients’ ability to benefit from psychotherapy through the reduction of sensations of threat, fear or even negative emotions.

The researchers added that the MDMA therapy wasn’t considerably affected by substance use disorder or risk of hazardous alcohol, severity of illness, dissociative subtype or adverse childhood experiences. In addition, they observed that while suicidal ideation was observed in patients who received MDMA as well as the placebo, MDMA didn’t heighten this risk.

In their conclusion, the researchers added that the common issues observed included transient, mild increases in heart rate and blood pressure. They noted that the therapy was generally well tolerated among the patients with post-traumatic stress disorder involved in the trial.

For the MAPS formulation to be approved federally, its MAPS Public Benefit Corp. subsidiary will have to file an application with the FDA this year. This, the organization noted last week, could mean that the federal agency could award approval as soon as 2024, which would make MDMA therapy more available.

In 2017, the FDA awarded a Breakthrough Therapy designation to MDMA, based on prior trials that were also sponsored by MAPS.  The organization also revealed that findings from 18 of its phase 1 and 2 trials would make up the basis for its New Drug Application.

When MAPS succeeds in getting MDMA approved by the FDA, it will be a big win for the entire psychedelics industry, including startups such as Seelos Therapeutics Inc. (NASDAQ: SEEL), which are also conducting drug-development programs involving psychedelic substances.

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