It looks as if we may soon have another treatment for postpartum depression: zuranolone. Sage Therapeutics and Biogen announced their plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone. Like brexanolone, zuranolone is a neurosteroid, an analogue of allopregnanolone which is a positive allosteric modulator of the GABA-A receptor. What distinguishes zuranolone from brexanolone is that it has much better oral bioavailability and thus does not have to be administered intravenously. It can be taken as an oral medication, similar to conventional antidepressants. Sage Therapeutics and Biogen will seek approval of a two-week, once-daily treatment option for MDD and PPD that produces rapid relief from symptoms within days.
In the second half of 2022, the initial submission package will seek approval of zuranolone for the treatment of major depressive disorder (MDD). An additional filing for postpartum depression (PPD) is anticipated in the first half of 2023. The decision to submit a separate and distinct filing for PPD is related to the completion of the ongoing PPD 301-SKYLARK Study for postpartum depression. The companies plan to start marketing for the approved indications as soon as possible pending the FDA’s approval.
Ruta Nonacs, MD PhD