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Oral Postpartum Depression Treatment Succeeds in Phase 3 Trial

January 07, 2019

By Reuters Staff and Terri Airov

Sage Therapeutics Inc's oral treatment for postpartum depression met the main goal of reducing symptoms of the condition, when compared with a placebo in a phase 3 clinical trial, the company announced Monday.

Women treated with 30 mg of SAGE-217 showed an improvement in the Hamilton Rating Scale for Depression (HAMD-17) that scores a patient on 17 different parameters, including anxiety and insomnia, the study results showed.

After 2 weeks of outpatient treatment, patients treated with SAGE-217 had a statistically significant improvement of 17.8 points on the HAMD-17, compared with 13.6 for placebo, with statistically significant reductions in HAMD-17 compared to placebo maintained through the end of the 4-week follow-up, the company said in a statement. A statistically significant difference was first observed on Day 3.

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Among the patients treated with SAGE-217 for 2 weeks, remission was achieved in 45%, as measured by the HAMD-17, compared with 23% of patients receiving placebo. At the end of Week 4, 53% of SAGE-217 patients achieved remission, compared with 30% of patients taking placebo.

Secondary endpoints were statistically significant and aligned with the primary endpoint of reducing symptoms, the company reported.

“These are strong and consistent data demonstrating a rapid, stable, and clinically meaningful improvement in PPD depressive symptoms in the SAGE-217 treatment group compared to placebo,” said Jeff Jonas, MD, chief executive officer of Sage. “This is our fifth consecutive positive study in mood disorders with our investigational medicines that utilize our innovative approach to GABA receptor modulation.”

The study involved 151 women diagnosed with severe postpartum depression (HAMD-17 ≥26).

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The results come months after the US 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.

SAGE-217 was well-tolerated, but 1 patient in each group discontinued treatment because of a side effect, the company said. In the SAGE-217 group, 58% reported adverse events, compared with 51% of the placebo group.

The most common adverse events in the SAGE-217 group included somnolence (12.8%), headache (9.0%), dizziness (7.7%), upper respiratory tract infection (7.7%), diarrhea (6.4%), sedation (5.1%), and nausea (3.8%).

"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," Stifel analyst Paul Matteis wrote in a note.

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Sage Therapeutics announces SAGE-217 meets primary and secondary endpoints in phase 3 clinical trial in postpartum depression [press release]. Cambridge, MA; Sage Therapeutics; January 7, 2019.

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