Shionogi Submits Zuranolone NDA in Japan for Major Depressive Disorder
Key Insights
Shionogi (search) has submitted a New Drug Application (NDA) in Japan for zuranolone, targeting the treatment of major depressive disorder (search) (MDD (search)).
The NDA is supported by Phase 3 trial data in Japan, which demonstrated statistically significant improvements in MDD (search) symptoms.
Zuranolone, a neuroactive steroid GABA-A receptor (search) modulator, has shown rapid efficacy, potentially addressing the need for faster-acting treatments.
Shionogi (search) & Co., Ltd. has announced the submission of a New Drug Application (NDA) in Japan for zuranolone, an investigational treatment for major depressive disorder (search) (MDD (search)). The submission is based on the results of a Phase 3 clinical trial conducted in Japan.
Phase 3 Trial Results
The Phase 3 validation trial assessed the efficacy, safety, and tolerability of zuranolone in 412 patients with moderate to severe MDD (search) who were not currently taking other antidepressant medications. The study met its primary endpoint, demonstrating a statistically significant improvement in the change from baseline in the HAM-D total score (a measure of MDD severity) in the zuranolone group compared to the placebo group at day 15. Furthermore, zuranolone exhibited a statistically significant improvement in MDD symptoms as early as day 3, highlighting its rapid onset of action.
Zuranolone: A Novel Treatment Approach
Zuranolone is a neuroactive steroid (NAS) GABA-A receptor (search) positive allosteric modulator (PAM). The GABA system, the major inhibitory signaling pathway in the brain and central nervous system, plays a crucial role in regulating brain function. Clinical trial results suggest that a 14-day course of once-daily oral zuranolone can rapidly improve MDD (search) symptoms without requiring dose adjustments.
Addressing Unmet Needs in MDD Treatment
With an estimated 5 million individuals affected by depression in Japan, MDD (search) represents a significant health burden. Current treatments often take weeks to achieve therapeutic effects, underscoring the need for fast-acting therapies. If approved, zuranolone could provide a novel and much-needed treatment option for individuals with MDD.
Strategic Collaboration
Shionogi (search) has exclusive rights to develop and commercialize zuranolone in Japan, Taiwan, and South Korea through a strategic collaboration with Sage Therapeutics. Zuranolone has already been approved by the U.S. Food and Drug Administration (FDA) as the first and only oral treatment specifically indicated for postpartum depression (search) (PPD (search)) in adults in the U.S., where it is marketed under the brand name ZURZUVAE™.