Earlier this year, the FDA approved Epidiolex, a medicine that treated two rare forms of epilepsy. It was the first medicine directly derived from the cannabis plant to gain approval from the federal agency. Now the FDA has made another first. As Rolling Stone reported, a U.K.-based company had their research on a psychedelic drug fast tracked by the federal government for the first time in U.S. history.
Compass Pathways has been granted “breakthrough therapy designation” for their research on psilocybin, which is the psychoactive ingredient in magic mushrooms. The company is studying the effects psilocybin on depression. In granting Compass Pathways this designation, the FDA is stating its belief that “the drug may demonstrate substantial improvement over available therapy.”
Previous research has demonstrated the unique ability magic mushrooms have on treatment-resistant depression while Johns Hopkins researchers have endorsed the psychedelic’s ability to treat anxiety, depression, and addiction. Compass Pathways’ research is being fast tracked because of the grand need for depression treatments across the country. Rolling Stone reported that “sixteen million Americans suffer from depression and approximately one-third of them are treatment-resistant.”
Compass Pathways’ research is also significant because of its scale. Their study will recruit 216 participants, which is 10 times more than the other major study focusing on psilocybin’s effectiveness alleviating treatment-resistant depression. Should all go well, psilocybin could be available for clinical trials by 2021, according to Multidisciplinary Association of Psychedelic Studies (MAPS) founder Rick Doblin.
That doesn’t mean psychiatrists will hand out mushrooms to patients, though. Instead a psychologist and/or therapy team will situate patients in the right mindset beforehand, then monitor their trip and help them process it afterwards.
Compass’ research could open the doors for other psychedelic researchers, particularly those focused on mental health treatments. Who knows. Maybe Denver will finally get their chance to decriminalize magic mushrooms, too.