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Psilocybin For Major Depression Granted Breakthrough Therapy By FDA61
An anonymous reader quotes a report from New Atlas:The US Food and Drug Administration (FDA) has granted psilocybin therapy a Breakthrough Therapy designation for the second time in a year, this time with a view on accelerating trials testing its efficacy treating major depressive disorder (MDD). This new FDA Breakthrough Therapy approval focuses on a seven-site, Phase 2 trial currently underway in the United States. Coordinated by a non-profit research organization called the Usona Institute, the trial is exploring the antidepressant properties of a single psilocybin dose in treating patients with major depressive disorder.
Last year's Breakthrough Therapy designation was targeted at the drug's efficacy for treatment-resistant depression (TRD). That particular clinical classification categorizes patients suffering from MDD who have not responded effectively to at least two different pharmacological antidepressant treatments during a current depressive episode. It is estimated between 10 and 30 percent of MDD patients fall into the category of TRD. The new FDA approval focuses on Usona's research into the broader condition of MDD, characterized by episodes of severe depression that last more than two weeks. Hundreds of millions of people around the world suffer from these kinds of acute major depressive episodes every year."The Usona Phase 2 trial plans to enrol 80 subjects, randomized to receive either a single active dose of psilocybin or an active placebo containing niacin," the report adds. "The methodology being trialed is similar to other psilocybin therapy studies, with a number of preparatory psychotherapy sessions preceding the active psychedelic dose, and a number of integrative psychotherapy sessions afterwards." It's estimated that the current Phase 2 trial will be completed by early 2021, where it should be able to move into larger Phase 3 trials if the results are positive.
The FDA also gave psilocybin therapy a Breakthrough Therapy status late last year. These trials should be completed sometime in 2020, "suggesting the next 12 to 24 months will offer some compelling and solid data into how effective this new psychedelic therapy actually is in treating several different forms of depression," reports New Atlas.
Last year's Breakthrough Therapy designation was targeted at the drug's efficacy for treatment-resistant depression (TRD). That particular clinical classification categorizes patients suffering from MDD who have not responded effectively to at least two different pharmacological antidepressant treatments during a current depressive episode. It is estimated between 10 and 30 percent of MDD patients fall into the category of TRD. The new FDA approval focuses on Usona's research into the broader condition of MDD, characterized by episodes of severe depression that last more than two weeks. Hundreds of millions of people around the world suffer from these kinds of acute major depressive episodes every year."The Usona Phase 2 trial plans to enrol 80 subjects, randomized to receive either a single active dose of psilocybin or an active placebo containing niacin," the report adds. "The methodology being trialed is similar to other psilocybin therapy studies, with a number of preparatory psychotherapy sessions preceding the active psychedelic dose, and a number of integrative psychotherapy sessions afterwards." It's estimated that the current Phase 2 trial will be completed by early 2021, where it should be able to move into larger Phase 3 trials if the results are positive.
The FDA also gave psilocybin therapy a Breakthrough Therapy status late last year. These trials should be completed sometime in 2020, "suggesting the next 12 to 24 months will offer some compelling and solid data into how effective this new psychedelic therapy actually is in treating several different forms of depression," reports New Atlas.
