Drug That Could Provide Near Immediate Relief For Postpartum Depression Gets OK From FDA
But the infusion will be expensive, averaging $34,000 per patient before discounts, and the women would have to stay in a medical center for two and a half days. Still, many experts cheered the new treatment that would offer relief much quicker than current drugs, which kick in after weeks if at all.
The New York Times:
F.D.A. Approves First Drug For Postpartum Depression
The first drug for women suffering postpartum depression received federal approval on Tuesday, a move likely to pave the way for a wave of treatments to address a debilitating condition that is the most common complication of pregnancy. The drug works very quickly, within 48 hours — a significant improvement over currently available antidepressants, which can take two to four weeks to have an effect, if they work at all. (Belluck, 3/19)
The Associated Press:
FDA Approves Drug For Treating Postpartum Depression
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. 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. (3/19)
The Washington Post:
First Drug Specifically For Postpartum Depression Is Approved
Tiffany Farchione, acting director of the psychiatry products division at FDA, said in a statement that the medication represented “an important new treatment option” for a potentially life-threatening condition. The drug, she said, is administered intravenously for 60 continuous hours. The approval requires that it be administered under strict safety conditions because of concerns it can cause “excessive sedation and sudden loss of consciousness.” The drug will be available to patients only through a restricted distribution program at certified facilities — such as doctors’ offices or clinics — where health-care providers can carefully monitor the patient. It will carry a “boxed warning,” which is the strongest warning required by the FDA. (McGinley and Bernstein, 3/19)
The Wall Street Journal:
Sage Therapeutics’ Drug For Postpartum Depression Gets FDA Nod
This is the second new depression drug the Food and Drug Administration has approved in March after decades that saw no major new treatments. The agency recently cleared Johnson & Johnson’s Spravato, which works differently than older medicines to treat depression in patients who have tried previous treatments but didn’t improve. Zulresso, also known as brexanolone, is designed to work differently than some of the older antidepressants. Studies showed that Zulresso did better at easing depressive symptoms in patients soon after dosing and when measured at 30 days after the treatment, compared with a placebo. (Loftus, 3/19)
Stat:
FDA Approves First New Drug Developed For Postpartum Depression
The Food and Drug Administration on Tuesday approved brexanolone, the first drug specifically targeted to treat postpartum depression — the most common complication of childbirth. Yet it’s a condition that often goes untreated because new mothers fear being stigmatized if they report symptoms. Brexanolone is the first drug developed by and approved from Sage Therapeutics. The Cambridge, Mass.-based biotech company will market the new medicine under the brand name Zulresso. (Feuerstein, 3/19)
In other news —
The New York Times:
Reports Of Breast Implant Illnesses Prompt Federal Review
Reports from thousands of women that breast implants are causing problems like debilitating joint pain and fatigue, claims long dismissed by the medical profession, are receiving new attention from the Food and Drug Administration and researchers. This may be a long-awaited moment of validation for tens of thousands of women who have been brushed off as neurotic, looking to cash in on lawsuits or just victims of chance who coincidentally became ill while having implants. (Grady and Rabin, 3/19)
