By Natalie Grover
Sage Therapeutics Inc said its drug alleviated symptoms of severe postpartum depression, meeting the main goal of a small mid-stage study and sending the company’s shares soaring.
About one in seven women experience postpartum depression that eventually interferes with her ability to take care of the baby and handle daily tasks, according to the American Psychological Association. There are no specific therapies for PPD. Existing options include standard antidepressants and psychotherapy.
Data on 21 patients showed that the drug, SAGE-547, achieved a statistically significant reduction in symptoms at 60 hours, compared to placebo, on a standard depression scale, Sage said in a news release reporting topline results from the study. (http://bit.ly/29KtPBI)
“This represented a greater than 20 point mean reduction in the depression scores of the SAGE-547 group at the primary endpoint of 60 hours through trial completion with a greater than 12 point difference from placebo. The statistically significant difference in treatment effect began at 24 hours, (p=0.006) with an effect that was maintained at similar magnitude through to the 30-day follow-up (p=0.01),” the company reported.
Typical antidepressants take about four-to-six weeks to take effect, trial investigator Samantha Meltzer-Brody told Reuters. “So the rapid onset of response of this drug is unlike anything else available in the field,” she said.
A woman with PPD can suffer a whirlwind of emotions, including severe anxiety, panic attacks, thoughts of harming herself or the baby, and feelings of worthlessness, shame, guilt or inadequacy.
Cambridge, Massachusetts-based Sage said it had initiated an expansion of the mid-stage study to determine optimal dosing for the injectable drug.
Sage is also evaluating the drug for use in super refractory status epilepticus (SRSE), a life-threatening seizure disorder, as well as essential tremor.