The U.S. Food and Drug Administration approved Sage Therapeutics Inc.'s Zulresso as the first treatment for a form of depression that occurs following childbirth.
Zulresso, or brexanolone, was given the green light to treat postpartum depression, in which women may experience thoughts about harming themselves or harming their child.
This form of depression is characterized by sadness or loss of interest in previously enjoyed activities and a decreased ability to feel pleasure. Symptoms might also include cognitive impairment, feelings of worthlessness or guilt as well as thoughts of suicide.
The Zulresso injection, which is administered as a continuous intravenous infusion over 60 hours, carries a boxed warning regarding serious risks, including excessive sedation or sudden loss of consciousness.
Zulresso comes with a Risk Evaluation and Mitigation Strategy program that mandates the drug to be given through a restricted distribution program at certified healthcare facilities. The program is meant to ensure that the healthcare provider can carefully monitor the patient during the entire infusion procedure.
The FDA approval is based on data from three clinical studies that tested the safety and effectiveness of Zulresso in women aged 18 and 45 years with moderate and severe postpartum depression.
A panel of outside advisers to the U.S. FDA voted 17-1 in November 2018, saying that the benefits of Zulresso outweighed the risks even though the loss of consciousness remained a primary concern among panelists. Later the same month, the U.S. drug regulator delayed its decision date on Zulresso by three months, seeking more time to determine whether the therapy should be approved.
There are currently no approved treatments for postpartum depression, which affects approximately one in nine women who have given birth in the U.S. or about 400,000 women annually, according to the Cambridge, Mass.-based company.
Sage Therapeutics said that Zulresso is expected to be available in late June following scheduling by the U.S. Drug Enforcement Administration, which is expected to occur within 90 days.