For the first time ever, the US Food and Drug Administration has approved the drug specifically developed for severe depression after childbirth. Sage Therapeutics' Zulresso, an IV drug given over 2 days has been approved by the agency. Sage said Zulresso will cost $34,000 without insurance, plus costs for staying in a hospital or infusion centre. Whether the treatment gets covered by insurance is determined by each insurance company, which also sets the out-of-pocket costs, depending on the plan. This move could pave way for alternate treatments for the most common pregnancy-related complication. Nearly 30 per cent American women suffer postpartum depression each year.
According to a survey conducted by Sage of new mothers with moderate or severe postpartum depression, half the women given Zulresso had depression end within 2 days, about double the rate of those in a comparison group given dummy treatments. Postpartum most of the times ends on its own within two weeks, but if gone untreated, in certain cases it can go on for months and even years and can prove to be life threatening even. “Postpartum depression is a serious condition that, when severe, can be life-threatening,” Dr. Tiffany Farchione of FDA's Division of Psychiatry Products said in a statement. “Women may experience thoughts about harming themselves or harming their child,” Zulresso's active ingredient, brexanolone, mimics a derivative of the naturally occurring hormone progesterone, levels of which can plunge after childbirth.
The infusion helps restore normal levels and emotions, according to Sage Chief Executive Dr. Jeff Jonas. A few women had more-serious problems, such as fainting and loss of consciousness. She expects the drug will be used to treat serious cases and patients not helped by antidepressants.
