FDA Approves Zulresso for Postpartum Depression

At a cost of $34,000, Sage Therapeutics' new drug promises to present coverage problems for insurers.

A drug that will be administered via IV over two and a half days to women suffering from postpartum depression just won FDA approval. Now comes the hard part for health plans: coverage decisions for Zulresso. Postpartum depression, which affects about 400,000 women a year, usually goes away on its own in a few weeks, but sometimes it can linger for weeks and even months. Antidepressants don’t always work, and even when they do they can take six to eight weeks to really kick in. It takes about two and a half days for Zulresso to work.

Sage Chief Executive Jeff Jonas, MD, tells the Associated Press that brexanolone, the active ingredient in Zulresso, mimics a derivative of progesterone. Plunging progesterone levels after childbirth contribute to postpartum depression.

There are side effects: sleepiness, drowsiness, headaches and even fainting and loss of consciousness. “Because those risks could result in injury, the FDA said it is restricting Zulresso's use to certified health care facilities where patients can be closely monitored throughout the infusion,” the AP reports.