Drug to treat postpartum depression approved in U.S.
Postpartum depression is a serious condition that, when severe, can be life-threatening
The U.S. Food and Drug Administration has approved the first drug specifically developed for severe depression after childbirth.
The agency on Tuesday approved Sage Therapeutics' Zulresso, an IV drug given over 2 ½ days.
Sage said Zulresso will cost $34,000 US 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.
In a company-funded study of new mothers with moderate or severe postpartum depression, half the women given Zulresso had depression end within 2 ½ days, about double the rate of those in a comparison group given dummy treatments.
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 psychotherapy.
In severe cases, the mother may have suicidal tendencies, may not want to nurse her child and might even harm the baby.
The Canadian Maternity Experiences Survey, published by the Public Health Agency of Canada in 2009, interviewed 6,421 new mothers across Canada. It assessed the mothers' emotional state and found that 7.5 per cent of the women had postpartum depression.
"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.
To be more specific, Zulresso is designed to reduce depression symptoms by targeting receptors of the neurotransmitter known as GABA. The drug is chemically identical to the hormone allopregnanolone.
Zulresso's label will include a so-called black box warning flagging risks of excessive sedation and sudden loss of consciousness, and will only be made available through a restricted distribution program at certified facilities where the patient can be monitored for these side-effects, the FDA said.
Patients will be advised to avoid activities such as driving until feelings of sleepiness have gone away.
A few women had more serious problems, such as fainting and loss of consciousness.
Zulresso appears safe for breastfeeding, said Dr. Kimberly Yonkers, a psychiatrist specializing in postpartum depression who heads Yale Medical School's Center for Wellbeing of Women and Mothers.
She expects the drug will be used to treat serious cases and patients not helped by antidepressants.
"It's going to depend on patient willingness to go into an infusion center and insurers being willing to pay for this," Yonkers added.
Sage plans to begin selling the drug in the U.S. in late June. It was not immediately clear if Sage plans to seek approval to market the drug in Canada.
The company is developing a second, similar treatment in pill form, and Marinus Pharmaceuticals is testing both a pill and IV therapy.
With files from Reuters and CBC News