New York, July 28 A pill used for postpartum depression (PPD) is safe for use and has shown to be effective in managing symptoms, results of a new study has shown.
PPD is a common perinatal complication experienced by one in eight women and has adverse maternal and infant outcomes.
Zuranolone, developed by Sage Therapeutics and Biogen, is an oral, once-daily neuroactive steroid pill used in a 14-day treatment course for patients with severe PPD.
“In the trial, zuranolone demonstrated significant improvements in depressive symptoms and was generally well tolerated, supporting the potential of zuranolone as a novel, rapid-acting oral treatment for PPD,” said researchers of the trial published in The American Journal of Psychiatry.
About 57 per cent of the women taking zuranolone experienced a 50 per cent or more improvement in their depressive symptoms at day 15, versus 38 per cent of women taking placebo.
At day 45, 61.9 per cent of the trial participants who received zuranolone compared to 54.1 per cent of women receiving placebo, experienced a 50 per cent or more improvement in their depressive symptoms.
“Postpartum depression is under recognised, undertreated and disruptive for those who live with the condition. We collaborate with researchers around the world in an effort to develop more rapid and effective therapies for the many women who need support,” said lead author Kristina M. Deligiannidis, professor at the Institute of Behavioral Science at the Feinstein Institutes, and the trial’s principal investigator.
“We have been working on neuroactive steroid research in PPD for nearly 15 years. The study follows previous successful clinical trials, and publishing its results is a pinnacle moment in treating postpartum depression,” she added.
The results showed rapid and clinically meaningful improvements in depressive symptoms at measured time points and have prompted a “priority review” by the US Food and Drug Administration (FDA).
A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
The FDA is expected to make a decision and take action on approval by August 5.
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