Sage Therapeutics and partner Biogen shared news that their phase III Skylark study has yielded promising results for women suffering from severe postpartum depression (PPD).
Sage Therapeutics and partner Biogen shared news that their phase III Skylark study has yielded promising results for women suffering from severe postpartum depression (PPD). The study included 200 women, divided into experimental and placebo groups, to evaluate the efficacy of zuranolone.
Zuranolone is an investigational oral drug that is intended to be taken once daily for two weeks. The drug’s mechanism modulates the GABA signaling pathway, which plays a strong role in brain function. Zuranolone has received Fast Track Designation from the U.S. Food and Drug Administration when indicated to treat PPD. The study results will support a planned New Drug Application (NDA) filing, which has been slated for 2023.
The phase III Skylark study is double-blinded and participants are randomly assigned to respective treatment or placebo groups. On Wednesday, Sage and Biogen announced that Zuranolone met the primary endpoint goal as well as all secondary endpoints. The primary endpoint measured the participants’ change from baseline in the Hamilton Rating Scale for Depression, at day 15. This scale uses 17 factors to create a score. Secondary endpoint measurements evaluated a change from baseline scoring according to the Clinical Global Impression Severity (CGI-S) scale at day 15, in comparison to scoring of the placebo subgroup, among other factors. Importantly, the women in the study did not experience an increase in suicidal thoughts, which was monitored using the Columbia Suicide Severity Rating Scale.
Barry Greene, chief executive officer at Sage, explained how the news extends hope to families affected by PPD.
“The positive outcomes of the Skylark Study are a critical step in our mission to help women suffering with postpartum depression find rapid relief from their depressive symptoms so they can get back to feeling like themselves,” he said. “Postpartum depression can be devastating for women and their families. If approved, zuranolone would be the first oral medication specifically indicated to treat PPD.”
PPD is a highly prevalent condition with unmet medical need. Roughly 500,000 women experience changes in sleep patterns, caregiving abilities, appetite, energy, self-esteem and general mental health. Some women develop suicidal thoughts as a side effect, perhaps the most worrying symptom. The first drug to be FDA approved for PPD was brexanolone, in 2019. However, this treatment is not ideal as it involves 60 hours of continuous intravenous administration in a medically monitored setting.
“Postpartum depression is frequently under-recognized, and it can take time for women to be clinically diagnosed and treated,” Katherine Dawson, M.D., head of the therapeutics development unit at Biogen said. “Our hope is to be able to offer an innovative treatment option to potentially reduce the overwhelming impact postpartum depression can have on women and their families.”
Zuranolone has an additional indication for patients with Major Depressive Disorder (MDD), for which Breakthrough Designation and Fast Track designation has been granted by the FDA. Collectively, zuranolone is the focus of the Landscape and Nest clinical development programs, which includes seven clinical studies on the safety and efficacy of zuranolone in PPD and MDD patients.
