The drug manufacturers Biogen and Sage Therapeutics Inc. have confirmed that the first oral pill sanctioned in the US for the treatment of postpartum depression is now available. The company announced that the drug, called Zurzuvae, will be available with a prescription.
The drug was approved by the US Food and Drug Administration in August and is currently available at specialty pharmacies. It can be directly shipped to patients.
Zurzuvae is administered as two 25-milligram capsules per day for 14 days to address postpartum depression (PPD) in adults, a condition that can affect approximately 1 in 7 new mothers following childbirth.
The manufacturers highlighted that patients participating in clinical trials with Zurzuvae had significant reductions in depressive symptoms compared to those receiving a placebo. These reductions were observed within three days and, in a Phase 3 clinical study, persisted for at least 45 days.
Postpartum depression symptoms can be incapacitating, and can include crying spells, challenges in forming a connection with the baby, sleep disturbances, and feelings of hopelessness. In severe cases, women with postpartum depression struggle to perform daily activities and may have recurrent thoughts of suicide, self-harm, or harm to the baby.
There are concerns about the accessibility of the medication, as it comes with a price tag of $15,900 per course before factoring in insurance coverage. However, the manufacturer Biogen and Sage said that it would launch a patient support program that includes financial assistance.
In the announcement, Chris Benecchi, chief business officer at Sage Therapeutics, said: “Innovations are only impactful if people can access them, and we will continue supporting the goal of broad and equitable access.
Our support programs aim, where possible, to help women with PPD who are prescribed Zurzuvae to have little to no copay, and to provide product at no cost for eligible patients with no insurance, as we believe that lack of insurance or financial means should not be a barrier to treatment access.”