The Food and Drug Administration on Tuesday approved the first drug specifically for postpartum depression – a debilitating condition that affects hundreds of thousands of women a year in the United States.
The disorder, which begins during pregnancy or within a month of childbirth, is characterized by feelings of worthlessness or guilt, or thoughts of suicide and is far more severe than the common “baby blues.” The condition can interfere with a mother’s ability to bond with an infant, which can affect the baby’s development. An estimated 400,000 women in the United States each year suffer from postpartum depression.
The newly approved drug, called brexanolone, will be marketed under the name Zulresso. Its manufacturer, Sage Therapeutics in Cambridge, Massachusetts, said the drug would likely cost $20,000 to $35,000 for a course of treatment.
The medication must be administered intravenously for 60 continuous hours and – under an FDA safety program that accompanied its approval – under the supervision of a health care professional, in a doctor’s office or a clinic, for example.
Experts called the drug a major advance for a serious illness that does not get enough attention. “We don’t have any treatments that are anywhere near this effective,” said Jess Fiedorowicz, a psychiatrist at the University of Iowa and a member of an FDA advisory panel that recommended agency approval of the drug. “So this is ground-breaking in that regard.”
Women diagnosed with postpartum depression currently are treated with antidepressants and psychotherapy, but the drugs take four to eight weeks to be fully effective and generally have only a small-to-moderate impact. The new drug, by contrast, takes effect quickly and lasts at least 30 days, according to clinical studies.
Still, said Fiedorowicz, the cost and method of administration could prevent women from getting it.
Samantha Meltzer-Brody, a psychiatrist at the University of North Carolina, Chapel Hill, who led the clinical trials for the drug, said the medication is such an improvement over current therapies that she doubts the IV administration will discourage its use. She noted postpartum depression, one of the most common complications of childbirth, is “under-diagnosed and neglected,” and that suicide is a major cause of maternal death.
“For women suffering, you can say, ‘You can come in and be treated and in 2.5 days it can go away, and not come back,’ ” she said. In clinical trials, she added, the IV administration did not prevent women from getting the drug.
The main component of drug is allopregnanolone, “a breakdown product” of the hormone progesterone that affects the GABA neurotransmitters, which have a role in mood regulation, said Meltzer-Brody. She added that the exact mechanism of action is unknown.
Sage is developing another drug to treat postpartum depression and major depressive disorder that would be administered as a once-daily pill. The medication recently showed good results in a phase 3 clinical trial. If approved, it could be a blockbuster, some industry analysts say.
The FDA’s advisory committee recommended approval of brexanolone in early November, but the agency delayed the green light to evaluate a safety concern: A small number of women who received the drug lost consciousness.
That problem is easily solved by lowering the dose, said Meltzer-Brody. But it is the reason why the agency is requiring that the drug be given under the supervision of a health professional’s supervision.
The approval is the second important one involving depression this year. Earlier this month, in biggest advance for depression in years, the FDA approved esketamine, also called Spravato, for people with major depression who have not responded to other treatments.
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