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FDA Granted Breakthrough Therapy Status to Psilocybin-Based Treatment

FDA Granted Breakthrough Therapy Status to Psilocybin-Based Treatment

The US Food and Drug Administration (FDA) granted psilocybin therapy for treatment-resistant depression a Breakthrough Therapy designation

The treatment demonstrated significant potential in early clinical evidence, allowing the FDA to assist and expedite subsequent development and review processes. In 2012, FDA's Breakthrough Therapy designation was created to present fast approval of drugs that display treatment advantages over conventional treatment options. The specific designation is directed at a phase IIb trial, which is currently underway across Europe and North America. Furthermore, research are underway to examine the optimal dose range for psilocybin for severe treatment-resistant depression.

Previous research studies reported that administration of one to two doses of the psychedelic agent reduced symptoms of depression significantly. Furthermore, currently the multi-center clinical trial conducted by Life Sciences Company COMPASS Pathways is underway, which expands on decades of work by researchers around the world. Moreover, researchers working with psilocybin from Johns Hopkins recently published a comprehensive article suggesting the drug needs to be rescheduled down to Schedule IV. The article highlighted the potential therapeutic benefits of the drug and its proven low rates of abuse, which demonstrated lack of physical dependence potential.

"The Breakthrough Therapy designation is a strong endorsement for the potential of psilocybin therapy," said Carhart-Harris, head of the Psychedelic Research Group at Imperial College London. "We look forward to learning more as further clinical studies are carried out, by our team at Imperial College as well as in COMPASS's multi-center trial." This latest step from the FDA to offer psilocybin a Breakthrough Therapy designation suggest that this previously stigmatized drug may have beneficial clinical uses. A significant psychedelic drug may become more available for clinicians and medical researchers in near future.


Mohit Joshi
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