The U.S. Food and Drug Administration (FDA) has issued the first approval for a drug specifically indicated for women suffering postpartum depression. An intravenous infusion of the drug brexanolone, which will be sold as Zulresso, is now the first drug ever approved for the treatment of the debilitating condition. Massachusetts-based biopharmaceutical company Sage Therapeutics (NASDAQ: SAGE), the company that developed the drug, says that the medication will be available in June.
Postpartum depression is a serious mental illness that is the most common complication of pregnancy, impacting as many as 1 in 7 American women after childbirth. Annually, more than 400,000 infants are born to mothers who are depressed. Without any treatment, postpartum depression can last for months or even years, keeping mothers from providing their babies with the care, bonding and nurturing necessary for healthy development.
Studies sponsored by Sage Therapeutics showed brexanolone was effective regardless of when postpartum depression symptoms began, working very quickly to provide relief within 48 hours. The treatment is administered as a single 60-hour IV drip and is required to be administered by a health care provider in a certified health care facility. Study participants reported mild side effects, including headache, dizziness, and excessive sleepiness.
Prior to this one, no antidepressant medication had been specifically FDA-approved to treat postpartum depression. The current treatment options for postpartum depression include counseling or therapy with a mental health professional along with traditional antidepressant medications. Unfortunately, currently available antidepressants can take up to four weeks to have an effect, and in some cases they do not work at all.
According to the company, the initial list price for Zulresso in the United States will be $7,450 per vial before discounts. For a full treatment, the projected average cost is $34,000 per patient. The actual number of vials used for the treatment can vary from patient to patient and discounts from health insurance providers may vary as well.