WASHINGTON, July 12 (UPI) -- An experimental drug for postpartum depression quickly eased women's symptoms, with no side effects and no remission among patients who experienced results from it, according to its manufacturer.
Sage Therapeutics reported 70 percent of women treated with the drug SAGE-547 experienced relief from postpartum depression within 60 hours of starting treatment and saw the benefits of the drug continue for at least 30 days, according to a press release.
The company's phase 2 trial of the drug is not part of an application for approval by the U.S. Food and Drug Administration, with the company still working to determine ideal doses, as well as develop an oral form of the drug.
"This is potentially one of the most important clinical findings in the pharmacologic treatment of postpartum depression to date," said Dr. Samantha Meltzer-Brody, an associate professor at the University of North Carolina, one of 14 sites involved in the trial. "The rapid onset of action of this drug observed in the trial is unlike anything else available in the field to date. The data show the potential of the drug to provide relief from the debilitating symptoms of postpartum depression, and to markedly decrease suffering in women who are severely affected."
The trial was slated to enroll 32 women with severe postpartum depression at the outset based on their score on the Hamilton Rating Scale for Depression, focusing on women who scored greater than a 26 on the scale who developed depression in the third trimester of pregnancy or within four weeks of childbirth.
Researchers matched 21 enrolled patients one-to-one with participants for a comparative placebo arm of the trial, finding patients receiving SAGE-547 often responded with 24 to 60 hours -- with a 20-point mean reduction in HAM-D score seen in 7 out of 10 patients on the drug, compared to 1 out of 11 of those in the placebo group.
After 30 days, 7 of 10 patients receiving the drug continued to experience remission of their condition, compared to just 2 of 11 in the placebo group. Additionally, the company reported a greater number of adverse events -- abnormal dreams, insomnia and anxiety -- were seen in the placebo group than the treatment group.
The company plans to expand the phase 2 trial to determine an ideal dose of the drug before the end of the year, as well as prepare a trial for a similar oral drug, SAGE-217, while eventually working with the FDA to develop the drugs for approval and marketing.
"These data speak for themselves," said Dr. Jeff Jonas, chief executive officer of Sage. "The unmet need in the postpartum depression patient population cannot be overstated. Given the societal impact of this condition, and the possible identification of a biological basis for treating these women, we are hopeful these data will point to a new understanding of this disorder and the development of effective therapies."