Sage Therapeutics and partner Biogen announced that they plan to submit a new drug application for their rapid-acting oral depression candidate, zuranolone, in the second half of 2022.
The NDA will seek approval for the candidate as a potential treatment of major depressive disorder (MDD), and then the partners will file a separate application — in 2023 — to get it approved for postpartum depression.
Oral zuranolone is taken for only two weeks and the hope is that it has a sustained antidepressant effect.
The partners' regulatory filing will include data from two completed late-stage studies — LANDSCAPE and NEST — along with data from ongoing clinical and pharmacology studies. According to the companies, clinical data on zuranolone demonstrated that the candidate achieved consistent, rapid, and sustained reductions in depressive symptoms.
Critics were skeptical of study results released In June 2021. Results from the phase 3 WATERFALL study in major depressive disorder showed only a small-to-moderate efficacy benefit over the placebo, and a waning benefit over time.
But the partners, fresh out of a pre-NDA meeting with the FDA, are confident in their safety and efficacy data. If approved, zuranolone will face a crowded market: competition from MDD drugs already approved, as well potential competition from treatments coming up the development pipeline, including VistaGen Therapeutics’ VTGN PH10 and Relmada Therapeutics’ RLMD REL-1017.