The road to recovery from postpartum depression and anxiety
A newly-approved drug to treat women suffering from postpartum depression — the first to specifically tackle the condition — won’t be easy or cheap to get.
That’s because the drug, called Zulresso or Brexanolone, requires an intravenous injection that lasts for 60 hours straight and has to be given to women at a certified clinic by a healthcare provider, according to the U.S. Food and Drug Administration’s news release announcing the drug’s approval.
“Because of the risk of serious harm due to the sudden loss of consciousness, patients must be monitored for excessive sedation and sudden loss of consciousness,” according to the FDA.
The federal agency said that during the 2.5-day infusion, “patients must be accompanied during interactions with their child(ren).”
Clinical trials showed that the drug improved women’s postpartum depression for at least 30 days after the infusion, the FDA said. Those trials studied women with both moderate and severe postpartum depression.
Postpartum depression, which can start during or after a woman’s pregnancy, is a major depressive episode in which sufferers become sad, feel less pleasure and sometimes lose interest in a doing things they used to enjoy, according to the FDA. In some cases, postpartum depression comes with suicidal thoughts, cognitive problems and “feelings of worthlessness or guilt,” the agency said.
While up to 80 percent of new moms experience the “baby blues” — mild “feelings of worry, unhappiness, and fatigue” for a week or two — about 15 percent of births come with postpartum depression, which can “interfere with a woman’s ability to care for herself or her family,” according to the National Institutes of Mental Health.
But the infusion isn’t cheap: It costs between $20,000 and $35,000, and that doesn’t include the price of staying in a clinic for more than two days to receive the treatment, the New York Times reports.
Sage Therapeutics, the company in Cambridge, Massachusetts, that manufactures the drug, said it anticipates insurance companies will cover that cost, according to the Times.
A pill version of the drug is in the works as well, according to STAT, a health news publication. That daily pill, if approved in a couple of years, would work like the injection and “could be worth billions of dollars,” STAT reports.
Even though the currently approved drug is costly and complicated, some doctors called it a breakthrough, CNN reports.
“There are no FDA approved antidepressants for postpartum depression, so approval of the first medication of its kind is a breakthrough for patients,” said Dr. Kristina Deligiannidis, who was involved in the trials and is director of Women’s Behavioral Health at Zucker Hillside Hospital in New York, according to the TV network.
The FDA said the most common side effects from Zulresso during clinical trials were dry mouth, loss of consciousness, sleepiness and flushing.