For the first time in history, the US Food and Drug Administration has approved a drug specifically indicated for the treatment of postpartum depression, which experts say offers new hope to women and physicians.
On Tuesday, the FDA announced the approval of an intravenous infusion of the drug brexanolone, which will be sold as Zulresso. It has been shown in clinical trials to work within hours to treat the symptoms of postpartum depression, a serious mental illness that impacts 1 in 9 new mothers after childbirth.
“Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond. This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option,” Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in a press announcement on Tuesday.
“Because of concerns about serious risks, including excessive sedation or sudden loss of consciousness during administration, Zulresso has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and is only available to patients through a restricted distribution program at certified health care facilities where the health care provider can carefully monitor the patient,” she said.
The treatment is administered as a single 60-hour IV drip and was found to have mild side effects, such as headache, dizziness or excessive sleepiness, but also sudden loss of consciousness. Yet some women may face barriers accessing this type of treatment, as it requires 60 hours of time. The drug will likely be priced around $20,000 to $35,000 per treatment, Sage Therapeutics, the company that developed the drug, confirmed.
The initial list price for Zulresso in the United States will be $7,450 per vial, resulting in a projected average course of therapy cost of $34,000 per patient before discounts, according to the company. The actual number of vials used before discounts can vary from patient to patient.
The medication will be available in June, said Dr. Jeff Jonas, CEO of the Massachusetts-based biopharmaceutical company that developed the drug. The drug will be available only through a restricted program called the Zulresso Risk Evaluation and Mitigation Strategy (REMS) Program that requires the drug be administered by a health care provider in a certified health care facility,the FDA said in a news release announcing the approval.
“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, the director of Women’s Behavioral Health at Northwell Health’s Zucker Hillside Hospital in New York, who was involved in two of the drug’s clinical trials as a researcher.
Without any treatment, postpartum depression can last for months or even years, according to the National Institute of Mental Health. Studies showed the brexanolone was effective regardless of when postpartum depression symptoms began.
In the United States, it’s estimated that every year, more than 400,000 infants are born to mothers who are depressed. Treatment options for postpartum depression have included counseling or therapy with a mental health professional and antidepressant medications, but no antidepressant medication has been specifically FDA-approved to treat postpartum depression. Also, antidepressant medications generally don’t provide an immediate relief of symptoms and may take several weeks to help.
“Brexanolone in phase II and III trials demonstrated rapid antidepressant effects,” said Deligiannidis, who is also an associate professor at the Feinstein Institute for Medical Researchand member of the Anxiety and Depression Association of America.
Those effects are something that Stephanie Hathaway, a Connecticut-based mother of two, knows well.