(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, sending its shares up 33 percent.
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, affecting one in nine women in the United States, according to the Centers for Disease Control and Prevention.
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.
Certain patients who were on Zulresso experienced loss of consciousness, which was flagged as a safety concern by FDA staff reviewers as well as members of an advisory panel to the health regulator during a meeting in November.
However, there were no reports of such loss of consciousness in SAGE-217 trial.
Stifel analyst Paul Matteis said the lack of reports of loss of consciousness would help quell investor concerns that stemmed from Zulresso.
SAGE-217 was well-tolerated, but one patient being administered the drug discontinued treatment because of a side effect, the company said.
“SAGE-217’s profile is highly encouraging and qualitatively looks cleaner to us than what one might observe/glean from the FDA label of other oral GABA drugs, such as Xanax,” Matteis wrote in a note.
Postpartum depression typically affects women from the third trimester of pregnancy or within four weeks after giving birth.
The company’s shares surged 33.3 percent to $130 before the bell.
Reporting by Ishita Chigilli Palli, Tamara Mathias and Saumya Sibi Joseph in Bengaluru; Editing by James Emmanuel