This week, life sciences company COMPASS Pathways announced that it has received “Breakthrough Therapy” designation from the United States Food and Drug Administration for its psilocybin therapy aimed at individuals with treatment-resistant depression.
Psilocybin, the main active ingredient in psychedelic mushrooms, is also known as Little Smoke, Magic Mushrooms, Purple Passion and Shrooms, according to the National Institute on Drug Abuse. Like many other hallucinogens, the drug can alter one’s perception, thoughts and feelings or cause hallucinations.
The FDA’s new designation is a significant milestone for psilocybin therapy, highlighting “the importance of supporting early research that can be translated to clinically meaningful outcomes,” company officials wrote in a news release. The designation will fast track the FDA’s review of the treatment for possible approval.
Researchers from Switzerland, the United Kingdom and the U.S. have been studying the therapy for many years. In fact, a study published in January found that the psychoactive compound helped revive emotional responsiveness in patients with treatment-resistant depression. Another showed that patients’ mental benefits after two psilocybin treatments lasted for weeks.
COMPASS Pathways will begin running the first large-scale psilocybin clinical trial for treatment-resistant depression in Europe and North America within the next two years. The company’s version of psilocybin comes in powder form, synthesized in the laboratory.
"This is great news for patients,” COMPASS executive chairman George Goldsmith said in a statement. “We are excited to be taking this work forward with our clinical trial on psilocybin therapy for treatment-resistant depression. The FDA will be working closely with us to expedite the development process and increase the chances of getting this treatment to people suffering with depression as quickly as possible.”
Approximately 350 million people around the world suffer from depression, according to the World Health Organization. And in the U.S. alone, nearly 7 percent of American adults had at least one major depressive episode in 2015.
While treatments such as antidepressants and psychotherapy exist, those with severe, treatment-resistant depression often involving suicidal thoughts have trouble finding help. Approximately 100 million around the globe are affected by such treatment-resistant depression.
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