Beitrag Di 25. Mai 2021, 07:00

Psychedelic Medicine Company Approved To Study Sublingual

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

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Psychedelic drug development company Cybin 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.

The company announced that the ethics board at the University of the West Indies Hospital in Jamaica granted approval this week.

Doug Drysdale, the company’s CEO, says the approval to start a clinical trial is a big step.

“I really think we have the opportunity to revolutionize how you treat mental illness,” says Drysdale, who worked in the pharmaceutical industry for 30 years before joining Cybin. “There’s nothing else out there today that could enable you to remove a person’s depressive symptoms for potentially months at a time.”

The start of the trial is still subject to final confirmation by Jamaica’s Ministry of Health.

The psychedelic renaissance is well under way. Nasdaq-listed Compass Pathways, a U.K.-based company that has patented a polymorphic form of psilocybin, and nonprofit Usona both have received breakthrough therapy designation from the FDA for psilocybin therapies. The Multidisciplinary Association for Psychedelic Studies recently released 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, which went public on Toronto’s NEO Exchange through a reverse takeover of a mining company in 2020, plans to bring its dissolvable oral strip dosed with psilocybin to market to help treat major depressive disorder when coupled with therapy. The company still has an uphill battle to gain approval by the U.S. FDA.

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