The Food and Drug Administration approved Tuesday a drug that will help women suffering from postpartum depression, but only very wealthy women will be able to afford the drug.
“Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child,” the FDA said in a Tuesday statement, announcing the approval of the drug. Women can access the drug brexanolone, also known as Zulresso, through a restricted distribution program at certified health care facility, according to the statement.
The drug is the first treatment for postpartum depression ever to be approved by the FDA. Approximately 400,000 women suffer from postpartum depression in the U.S. every year.
The approval comes after two successful clinical trials showed major improvement in women suffering from postpartum depression after taking the drug. The drug is administered intravenously for a total of 60 hours and patients are monitored throughout.
— FDA Drug Information (@FDA_Drug_Info) March 19, 2019
“This can potentially transform women’s lives and that of their families,” said Sage Therapeutics CEO Steve Kanes, whose company developed the drug, NBC News reported Tuesday. “We’re talking about a single treatment that has durable effects,” he said. “This really is a one-time intervention that gets people on their way. It’s transformative.”
Risks include loss of consciousness and abnormal oxygen levels in the blood, according to the FDA which hasn’t yet decided if the drug is safe for women who are breastfeeding.
The drug infusion costs between $20,000 to $35,000, according to NBC.
“This is for postpartum depression, but it is a step in understanding how we treat depression more broadly,” said brexanolone trial investigator Dr. Samantha Meltzer-Brody. “We have had the same treatments for depression for 30 years. There’s an enormous need for new, novel ways to treat depression, and to treat it quickly.”
Meltzer-Brody is also the director of the perinatal psychiatry program at the University of North Carolina at Chapel Hill, according to NBC.
The FDA recently approved a nasal spray containing ketamine as a treatment for severe depression. Ketamine is a medication used largely by veterinarians as an anesthetic. It has hallucinogenic effects and produces a trance-like state. (RELATED: FDA Recommends New Nasal Drug For Treating Depression)
“I woke up from a nap, and the thoughts were gone. And they never came back,” said Stephanie Hathaway who suffered from postpartum and participated in a brexanolone trial. “And then hour after hour, I got my energy back. I got my appetite back. I was eating because I was actually hungry, not because people were making me eat,” she said, according to NBC.
The drug will be available in June, according to CNN.
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