Psychedelic Medicine Company Approved To Study Sublingual Psilocybin For Major Depressive Disorder

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A psychedelic medicine company will launch a phase two clinical trial on its sublingual formulation of psilocybin, the psychedelic compound found in “magic mushrooms”, for patients with Major Depressive Disorder later this year

data from its phase three clinical trial with MDMA-assisted therapy for post-traumatic stress disorder, showing that 67% of participants who received three treatments no longer qualified for a PTSD diagnosis and 88% experienced a clinically meaningful reduction in symptoms. Other companies like MindMed, which is studying LSD for anxiety and a modified version of ibogaine to treat opioid-use disorder, have also listed on Nasdaq.

Cybin’s phase two study will be conducted in two parts at Jamaica’s University of West Indies Hospital. The first part of the clinical trial will consist of a Phase IIa study of 40 patients to identify the equivalent dose of Cybin’s sublingual psilocybin formulation compared with a 25 mg pill of psilocybin. Cybin’s sublingual film is designed for rapid absorption, a faster onset, and a shorter duration.

Cybin is starting with psilocybin, but the company is developing novel molecules based on other psychedelic compounds. The company has filed 12 provisional patent applications for novel psychedelic compounds.

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