(Reuters) – Sage Therapeutics Inc said on Monday its oral treatment for postpartum depression met the main goal of reducing symptoms of the condition, when compared to a placebo in a late-stage study.
Patients treated with SAGE-217 showed an improvement in the Hamilton Rating Scale for Depression that scores a patient on 17 different parameters, including anxiety and insomnia after two weeks of treatment, the study results showed. The improvements were maintained until the end of the follow-up period in the fourth week, Sage said.
Postpartum depression is considered the most common medical complication linked to childbirth, which typically affects women from the third trimester of pregnancy or within four weeks after giving birth. It affects one in nine women in the United States, according to the Centers for Disease Control and Prevention.
The drug was well-tolerated but one patient being administered SAGE-217 discontinued treatment because of a side effect, the company said.
The results come months after the U.S. Food and Drug Administration extended the review of the Massachusetts-based drug developer’s lead drug Zulresso, an injectable that aims to treat postpartum depression, by three months.
Reporting by Ishita Chigilli Palli and Tamara Mathias in Bengaluru; Editing by James Emmanuel