33% of 14 million American’s suffering from clinical depression get no relief from today’s approved antidepressant drugs. A new treatment approach involving neurosteroids is on the horizon however that may be more effective. The strategy of using neurosteroids was hatched at Washington University School of Medicine in St. Louis, where its Taylor Family Institute for Innovative Psychiatric Research has been focused on developing more effective psychiatric drugs.
Partnership with Sage Therapeutics
Washington University’s Taylor Family Institute for Innovative Psychiatric Research partnered with Sage Therapeutics to develop a neurosteroid drug that was shown to be more effective in a recent clinical trial.
With 89 patients, 45 of whom were randomly chosen to receive a neurosteroid called SAGE-217, while the other 44 received an inactive placebo—researchers uncovered that the investigational drug reduced symptoms of depression in less than two week. The results were recently published in the New England Journal of Medicine.
The Makers of Zulresso
Sage has already developed a depression drug approved for clinical use called Zulresso—recently approved by the Food and Drug Administration (FDA).
What is SAGE-217?
Known as Zuranolone, SAGE-217 is an investigational medication which is under development for the treatment of major depressive disorder, postpartum depression, essential tremor, Parkinson’s disease, insomnia, and seizures. It is a synthetic orally active, inhibitory pregnane neurosteroid, and acts as a positive allosteric modulator of the GABAA receptor.
The drug was developed as an improvement of allopregnanolone (brexanolone) with high oral bioavailability and a biological half-life suitable for once-daily administration. SAGE-217 is in a Phase III clinical trial for major depressive disorder among other indications.
The Major Depressive Disorder Study
The study is a Phase III, open-label, 1 year study of the safety, tolerability and need re-treatment with SAGE-217 in adult subjects with major depressive disorder. The study started February 2019 and runs through till April 2021. The sponsor seeks 73 clinical investigational sites and 600 participants. Sage Therapeutics doesn’t identify its investigational sites by name.
Charles F Zorumski, MD, the Samuel B. Guze Professor and head of the Department Psychiatry, directs the Taylor Family Institute and was one of the authors of the recent study published in the New England Journal of Medicine. Dr. Zorumski was interviewed by Jim Dryden with the Washington University School of Medicine news publication.
Call to Action: For those interested in breakthrough depression treatments this interview may represent an interesting read.