This website is made possible by third party financial support from Sage Therapeutics, Inc. and Biogen Inc.

This website is made possible by third party financial support from Sage Therapeutics, Inc. and Biogen Inc.

Zuranolone Rapidly Reduces Depressive Symptoms in Patients With Major Depressive Disorder

Zuranolone Rapidly Reduces Depressive Symptoms in Patients With Major Depressive Disorder

June 29, 2021

Investigational drug studies are being done to treat major depressive disorder more effectively.

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A two-week, once-daily oral treatment shows promise for rapid treatment of major depressive disorder, according to data shared from the phase 3 WATERFALL trial.

Researchers posited zuranolone is a two-week, once-daily new class of oral drug that could be more effective against major depressive disorder than monoamine-based antidepressants requiring daily treatment and continuous use to remain effective.

A total of 543 patients enrolled in the phase 3, randomized, placebo-controlled WATERFALL trial to evaluate the efficacy and safety of zuranolone 50 mg in adults with major depressive disorder. Patients were randomized to receive zuranolone or placebo.

The primary endpoint was statistically significant reduction in depressive symptoms compared with placebo at Day 15, measured by the change from baseline on the Hamilton Rating Scale for Depression (HAM-D-17).

At baseline, patients in the zuranolone treatment arm (n=268) had a mean score of 26.8 and patients in the placebo arm (n=269) had a mean score of 26.9. Patients treated in the zuranolone arm experienced a -14.1 change from baseline in HAMD-17 score, compared to -12.1 in the placebo arm, at Day 15.

Researchers found patients with a demonstrated response on Day 15 retained 86.1% of their HAMD-17 improvement at Day 42, 4 weeks after daily treatment ended.

The safety profile of zuranolone was consistent with existing clinical data and treatment was generally well-tolerated. The most common treatment-emergent adverse events were mild to moderate somnolence (15.3%), dizziness (13.8%), headache (10.8%) and sedation (7.5%). Four total patients reporting serious adverse events throughout the trial were split evenly in the zuranolone and placebo arms.

“I’m really excited about these breakthrough data: we know MDD is episodic and zuranolone has the potential to treat episodically…” wrote Anita H. Clayton, MD, University of Virginia School of Medicine, VA. “…These data suggest that this treatment, if approved, has the potential to work fast with a short-course of therapy that is well-tolerated, with the effect maintained over the long-term. This will empower my patients to think differently about their depression and treatment, and to rapidly return to their life.”

“Depression is not an identity, it’s an episodic disorder that we hope in the future to be able to treat quickly with treatments that are well-tolerated and with benefits that last,” Dr Clayton concluded.

These results have the potential to be practice-changing for treatment of major depressive disorder. Full data will be presented at future scientific conferences. —Kaitlyn Manasterski

 

Disclaimer: Sage Therapeutics provides funding for the Clinical Topics in Depression site.

Reference:

Sage Therapeutics and Biogen Announce Positive Pivotal Phase 3 Results for Zuranolone, an Investigational Two-Week, Once-Daily Therapeutic Being Evaluated for Major Depressive Disorder [news release] Sage Therapeutics, Biogen: June 15, 2021. https://www.businesswire.com/news/home/20210615005402/en/Sage-Therapeutics-and-Biogen-Announce-Positive-Pivotal-Phase-3-Results-for-Zuranolone-an-Investigational-Two-Week-Once-Daily-Therapeutic-Being-Evaluated-for-Major-Depressive-Disorder  Accessed June 24, 2021.