Zuranolone is a rapid-acting, once-daily, 14-day oral short course therapy for adult patients with major depressive disorder and postpartum depression.
Biogen Inc and Sage Therapeutics have completed a rolling submission to the FDA of a New Drug Application for zuranolone for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). The investigational drug is being evaluated as a rapid-acting, once-daily, 14-day oral short course therapy for adult patients with MDD and PPD.
The NDA submission for zuranolone includes data from the LANDSCAPE and NEST clinical development programs. The LANDSCAPE program includes 5 studies (MDD-201B, MOUNTAIN, SHORELINE, WATERFALL, and CORAL) of zuranolone conducted in adult patients with MDD. The NEST program includes 2 studies (ROBIN and SKYLARK) of zuranolone in adult women with PPD.
“Based on the data in the LANDSCAPE and NEST programs, we believe that zuranolone has the potential to be a meaningful new therapy for depression,” Priya Singhal, MD, MPH, head of Global Safety and Regulatory Sciences and interim head of R&D at Biogen, said in a press release. “We look forward to working with the FDA as this filing progresses.”
Zuranolone is a neuroactive steroid with a novel mechanism of action as a positive allosteric modulator of GABA-A receptors. In patients with depression, zuranolone may help to rapidly rebalance dysregulated neuronal networks to help improve brain function. The drug targets brain networks that are responsible for functions such as mood, arousal, behavior, and cognition.
Thus far, zuranolone has shown rapid and sustained improvement of depressive symptoms and has been found generally well-tolerated with a consistent safety profile. The FDA granted zuranolone with Fast Track Designation in 2017 and Breakthrough Therapy Designation in 2018 for MDD. The FDA granted Fast Track Designation to zuranolone for PPD in 2022.
At the 2022 Psych Congress in September, 11 new analyses showed the potential of the medication to improve the symptoms of depression. The ongoing open-label, longitudinal SHORELINE study in patients with MDD (30 mg cohort, 50 mg cohort) found the median time to the first repeat treatment course for patients who responded to the initial 14-day treatment course was 135 days for the completed 30 mg cohort and 249 days for the ongoing 50 mg cohort.
The research further supports zuranolone as a potential episodic treatment for people with MDD, according to the study authors. Some of the key findings from the completed 30 mg cohort of the SHORELINE study, other clinical data and health economics and outcomes research, and patient survey, included:
“Mental health is a highly underserved area with an urgent unmet need for innovative therapies. We need to rethink how MDD and PPD are treated. Existing treatments often take weeks to months to provide symptom relief, and patients may need to cycle through multiple treatment options to fully address their symptoms. People with MDD and PPD deserve better,” Laura Gault, MD, PhD, chief medical officer at Sage, said in a press release. “We believe that zuranolone, if approved, could evolve the way depression is treated and this submission brings us one step closer to that goal.”
Biogen and Sage Therapeutics Complete Rolling Submission of New Drug Application for Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression. Biogen Inc. News release. December 6, 2022. http://media.biogen.com/news-releases/news-release-details/biogen-and-sage-therapeutics-complete-rolling-submission-new