Sage Therapeutics’s Postpartum Depression Drug Shows Positive Results

Sage Therapeutics announced that its drug, SAGE-547, alleviated symptoms of severe postpartum depression, meeting the primary endpoint of a small Phase 2 study and sending the company’s shares soaring more than 44 percent Tuesday in early trading.

What’s especially significant is the drug’s ability to statistically reduce symptoms of postpartum depression at 60 hours. Currently, there are no specific treatments for postpartum depression. Standard antidepressants can take around four to six weeks to take effect.

Postpartum depression affects up to 1 in 7 women after childbirth. Symptoms include severe anxiety, panic attacks, irritability, reduced concentration, trouble sleeping, and feelings of inadequacy. Approximately 125,000 cases of severe postpartum depression and diagnosed each year in the U.S., estimates Sage Therapeutics.

The trial, which included 21 patients, found 70 percent of women with severe postpartum depression treated with an injection of SAGE-547 achieved complete remission after 60 hours compared to under 10 percent of women treated with a placebo injection.

Moreover, the complete remission was maintained through to the 30-day follow up.

“This is potentially one of the most important clinical findings in the pharmacologic treatment of postpartum depression to date,” Samantha Meltzer-Brody, the study’s investigator, said in a press release.

To determine the drug’s success, study researchers looked at patients’ HAM-D scores, a rating scale used to provide an assessment of depression. After 60 hours, the women treated with SAGE-547 had a 20-point reduction in their HAM-D score, or more than 12 points greater than the women receiving placebo injections.

A patient is said to be in complete remission when a HAM-D score drops to 7 or below. In the trial, seven of the 10 women treated with SAGE-547 achieved a complete remission at 60 days. And at 30 days, those seven women remained in complete remission. Comparatively, one of the 11 women treated with placebo achieved a complete remission at 60 hours, and two women remained in complete remission at 30 days.

All study participants tolerated the drug well with no serious adverse events, according to the report.

The trial follows a study from last year, in which the drug SAGE-547 achieved complete remission of severe postpartum depression in four women. Critics said this prior study was too small to draw conclusive results.

Sage Therapeutics is beginning an expansion study, which will include different doses of the drug and will enroll women with moderate and severe postpartum depression before the end of the year. The company said it will seek regulatory input in developing the medication for this indication.

SAGE-547 is an allosteric modulator of both synaptic and extra-synaptic GABA receptors in the brain. The specific ways in which SAGE-547 targets these GABA receptors is an indicator of the drug’s benefit against central nervous system diseases, including anxiety and postpartum depression.

The company is also testing its drug, SAGE-547, in a Phase 3 study of patients with super-refractory status epilepticus (SRSE), a severe form of epilepsy.