Novel, Rapid-Acting Antidepressant Awaits FDA Approval

A couple of weeks in the past, Biogen and Sage Therapeutics introduced that they’ve accomplished a rolling submission to the FDA of a New Drug Application (NDA) for zuranolone for the therapy of main depressive dysfunction (MDD) and postpartum despair (PPD). The investigational drug is being evaluated as a rapid-acting, once-daily, 14-day oral brief course remedy for grownup sufferers with MDD and PPD.

Zuranolone is just like brexanolone, which was authorized in 2019 by the FDA for the therapy of PPD, and is a neuroactive steroid with a novel mechanism of motion as a optimistic allosteric modulator of GABA-A receptors.  

Information from the Phase 3 SKYLARk study demonstrated {that a} 15-day course of zuranolone was superior to placebo in ladies with extreme PPD. By day 3, ladies receiving zuranolone skilled a higher discount in HAM-D scores than ladies receiving placebo (imply discount, 9.5 vs 6.1; P = 0.0008).  The distinction in imply HAM-D scores steadily elevated as much as day 15. At day 15, the imply discount in HAM-D scores was 15.6 in ladies receiving zuranolone vs. 11.6 within the placebo group (distinction -4.0; P = 0.0007). At day 45, ladies handled with zuranolone continued to point out a higher discount in HAM-D scores in comparison with ladies receiving placebo.

Trying Ahead

That is thrilling. If zuranolone is authorized, we’d have a quickly performing antidepressant with a very good security profile.  Zuranolone was usually well-tolerated; the commonest hostile occasions (AEs) included headache, somnolence, dizziness, and sedation. Whereas the SKYLARK examine seemed particularly on the therapy of despair in postpartum ladies, different research included within the  LANDSCAPE medical improvement applications indicated that zuranolone is efficient in men and women with non-postpartum episodes of main depressive dysfunction. 

Ruta Nonacs, MD PhD