"Dramatic decrease" of symptoms seen in mothers on postpartum drug

The U.S. Food and Drug Administration

specifically developed for severe depression after childbirth.

On March 19, the agency approved Sage Therapeutics' Zulresso, an IV drug given over 2 ½ days.

WVLT News spoke to Dr. Stephanie Cross, an assistant professor in the Department of OBGYN at the University of Tennessee Medical Center about what makes the new drug so unique.

Cross said part of it is that the drug is "rapid onset and it takes 60 hours and that's it. It doesn't take any follow up therapy. So, for patients with really severe symptoms...it gives us another tool in our tool box to treat these women rapidly and effectively."

Cross believes that the drug's rapid onset feature could "hopefully prevent a tragedy."

"Depression in general is a huge percentage of the patient population in postpartum patients. It's anywhere from 10 to 15 percent, and that's out of four million deliveries a year in the United States, so it's a big number," she add.

She said that this drug being specifically used to treat postpartum is a big deal. She said innovation is important, but with the revelation of the new drug, postpartum also gets awareness. It "hopefully removes some of the stigma for those women asking for help and no longer suffering in silence."

Sage said Zulresso will cost $34,000 without insurance, plus costs for staying in a hospital or infusion center. 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.

"That number seems huge," Cross said. "The flip side of that is it's 60 hours. Fifty percent of women had a dramatic decrease in their symptoms. Seventy percent of women after 60 hours had complete resolution of their depression symptoms."

"I think certainly, because of the cost, this isn't going to be front-line therapy, but at least initially until we see how insurance companies, Medicare and Medicaid are going to cover this, it may be at first that we reserve this for the more severe patients," Cross said.

Postpartum depression affects about 400,000 American women a year. It often ends on its own within a couple weeks, but it can continue for months or even years. It can be treated with antidepressants, which can take six to eight weeks to work and don't help everyone, or with counseling.

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.

The drug's most common side effects were sleepiness, dizziness and headaches. A few women had more-serious problems, such as 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.