Sage Therapeutics and Biogen’s zuranolone is heading off to the FDA for consideration in treating major depressive disorder (MDD) as a two-week, once-daily drug to bridge the time it takes for traditional therapies to kick in.
The companies announced that a rolling submission has been kicked off, and the application is expected to be completed in the second half of the year, according to a Monday release.
Zuranolone was found to quickly relieve symptoms of depression in a phase 3 study called CORAL, which was part of the larger LANDSCAPE program, but concerns remain about how durable the treatment effect is. Sage has positioned the therapy as a first-of-its-kind fast-acting option for patients who begin treatment for depression, as the usual medications can take up to a month to become active.
The treatment also does not come with common side effects of depression therapies, such as challenges associated with discontinuing dosing, Sage said.
Sage said the FDA package includes data from completed studies from the LANDSCAPE and NEST programs. The former is a clinical program that found zuranolone benefited patients with MDD who also had elevated anxiety.
Once the rolling submission is complete, Sage plans to follow up with a filing in postpartum depression in the first half of 2023.
The FDA previously granted fast-track and breakthrough-therapy designations to zuranolone.