Patients With MDD Show Rapid Symptom Improvement With Investigational Drug Zuranolone

Patients taking zuranolone saw rapid improvements in depressive and elevated anxiety symptoms, according to data presented by Sage Therapeutics and Biogen at the American College of Neuropsychopharmacology Congress (ACNP) in San Juan, Puerto Rico.

Zuranolone, an investigational once-daily oral neuroactive steroid GABA-A receptor positive allosteric modulator, is in development to treat MDD and postpartum depression (PPD).

The presented studies, SHORELINE and WATERFALL, are part of the LANDSCAPE clinical program. Researchers aimed to further the understanding of the potential efficacy and safety profile of zuranalone for major depressive disorder (MDD) treatment.

In the phase 3 placebo-controlled WATERFALL study, participants aged 18 to 64 years diagnosed with MDD received 50mg of zuranolone daily. Compared to placebo, they demonstrated “rapid improvements” in depressive and anxiety symptoms as measured by the hamilton anxiety rating scale (HAM-A) at days 8 and 15.

“The analysis conducted evaluating zuranolone’s effects on measures of anxiety in patients with MDD is critical. Symptoms of anxiety are highly present in patients with depression, which can pose unique challenges to care,” said Chief Executive Officer of Sage Therapeutics, Barry Greene.

NDA Submission for Major Depressive Disorder and Postpartum Depression Treatments

In a subgroup of patients aged 65 and older (n=96) as part of the SHORELINE study, 30 mg zuranolone was generally well-tolerated. Efficacy and safety results for the initial 2-week dose treatment course were comparable to the results in the general study population.

“We are also pleased with the data for those 65 and older, who can struggle with current therapies to treat their depression. Zuranolone has consistently demonstrated rapid and sustained improvements in depressive symptoms and a well-tolerated safety profile in our clinical trials to date without the adverse events that are often associated with discontinuation of standard of care antidepressants,” said Greene.

Similar results for zuranolone were seen across the LANDSCAPE program.

“As we continue to evaluate the totality of the data from the LANDSCAPE clinical develop program—which includes the Phase 3 WATERFALL and SHORELINE Studies—we aim to gain a more comprehensive understanding of how zuranolone may one day be a valuable option for people worldwide who seek a new way to treat depression,” said Priya Singhal, MD, MPH, head of global safety and regulatory sciences, interim head of research and development, Biogen, Cambridge, Massachusetts.

Reference

Sage Therapeutics and Biogen announce new analyses from the LANDSCAPE clinical development program of Zuranolone in MDD presented at the American College of Neuropsychopharmacology (ACNP) Congress. News Release. BusinessWire; December 08, 2021.