FDA fast-tracks psilocybin treatment for major depressive disorder

pharmafile | November 25, 2019 | News story | Sales and Marketing Controlled Substance Act, FDA, breakthrough therapy, major depressive disorder, psilocybin 

The FDA has granted a Breakthrough Therapy designation to the Usona Institute for its trial use of psilocybin in the treatment of major depressive disorder (MDD), with the view of accelerating trials testing its efficacy.

Non-profit research organisation The Usona Institue is examining the antidepressant properties of a single psilocybin dose in treating patients with major depressive disorder.

Dr Charles Raison, the Director of Clinical and Translational Research at Usona said that it is ‘‘groundbreaking’’ that the FDA acknowledges that MDD is an unmet medical need and that ‘‘psilocybin may offer a significant clinical improvement over existing therapies.’’ He added:  ‘‘Given that there is so much complexity with psilocybin and that Usona is charting new ground, these interactions will ensure that Usona and the FDA are aligned in approaching the development programme with acceptable best practices.’’

The new FDA status follows Usona’s recent launch of their Phase 2 clinical trial which will include 80 participants around the US. The patients will randomly receive either an active dose of psilocybin or an active placebo that covers niacin. The estimated completion for Phase 2 is early 2021.

The FDA’s Breakthrough Therapy designation was introduced back in 2012 as a way or speeding up the approval for drugs that display treatment advantages over current options or life threatening conditions. It also offers development assistance to whatever organisation is sponsoring the research.

The designation given to Usona follows the FDA granting Breakthrough Therapy status in October 2018 to a similar psilocybin therapy from COMPASS Pathways for treatment-resistant depression. This specifically targeted patients suffering from MDD who have not responded to at least two different pharmacological antidepressant treatments during a depressive episode.

Psilocybin is the key psychedelic compound found in magic mushrooms, which cause hallucinogenic effects when eaten. The FDA’s recent steps to endorse treatment using psilocybin means that the drug will have to be removed from the Schedule I of the Controlled Substance Act, which is reserved for drugs with no accepted medical use.

Conor Kavanagh

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