Sage Therapeutics, Inc. (SAGE) and Biogen Inc. (BIIB) announced Monday additional data from the Phase 3 SKYLARK Study of zuranolone in adult women with postpartum depression or PPD.
The companies said they have initiated a rolling submission of a New Drug Application or NDA to the U.S. Food and Drug Administration for zuranolone in the treatment of MDD and PPD, and plan to complete the NDA filing in the second half of 2022.
PPD is one of the most common medical complications during and after pregnancy, which can have a serious negative impact on a woman.
Zuranolone (SAGE-217/BIIB125) is a once-daily, 14-day, investigational drug in development for the treatment of major depressive disorder or MDD and PPD.
If approved, zuranolone would be the first oral medication specifically indicated to treat PPD.
The companies presented the data at the 35th European College of Neuropsychopharmacology (ECNP) Congress, taking place October 15-18, 2022, in Vienna, Austria.
As announced earlier, the SKYLARK Study achieved the primary and all key secondary endpoints, with study participants demonstrating rapid and significant improvements in depressive symptoms as early as Day 3 that were sustained through Day 45.
Women with PPD who were treated with zuranolone 50 mg showed a statistically significant and clinically meaningful improvement in depressive symptoms at Day 15, the primary endpoint, compared to placebo.
In the presentation at ECNP, additional secondary endpoint data demonstrated that a higher proportion of patients in the zuranolone 50 mg arm achieved a HAMD-17 response as compared with the placebo arm at Days 3, 8, 15, 21, and 28.
Data also showed that a higher proportion of patients in the zuranolone arm achieved HAMD-17 remission than in the placebo arm from Day 3 through Day 45.
Additional secondary endpoints showed further evidence of the potential impact of zuranolone on the reduction of other PPD related symptoms, including anxiety in these patients. Treatment with zuranolone was shown to significantly improve symptoms of anxiety at Days 3, 8, 15, and 45 when compared to placebo.
Kristina Deligiannidis, Principal Investigator of the study, said, "Rapid symptom relief is critical for women with PPD, because delays in treatment efficacy can negatively impact resolving depressive symptoms and overall clinical outcomes for mother and baby. …. There are currently no oral therapies approved for PPD and we desperately need new treatment options to help women get well as soon as possible and stay well."
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