The first oral pill approved in the United States to treat postpartum depression is now available by prescription, according to the drugmakers.
The US Food and Drug Administration approved the therapy, called Zurzuvae, in August. The product, which is now at specialty pharmacies, can be shipped directly to patients, Biogen and Sage Therapeutics Inc. said in an announcement Thursday.
However, the medication will cost $15,900 per course before insurance, raising some concerns about how many people will be able to access it.
Zurzuvae is given as two 25-milligram capsules per day for 14 days to treat adults with postpartum depression or PPD, a serious mental illness that can develop in about 1 in 7 new mothers after childbirth.
The drugmakers noted that people taking Zurzuvae in clinical trials had higher reductions in their depressive symptoms compared with those taking a placebo, and the reductions were seen within three days and, in a Phase 3 clinical study, lasted through at least 45 days.
"Having an option like Zurzuvae that can work at Day 15 and improve symptoms in as early as three days has the potential to make a profound difference in the lives of women with PPD," Dr. Kristina Deligiannidis, a professor at the Feinstein Institutes for Medical Research in New York who has been the principal investigator on national multisite clinical trials that led to Zurzuvae's approval, said in the announcement. "This milestone is hopefully a catalyst for more systemic change for women with PPD including a much-needed increase in screening, diagnosis and treatment across physician specialties."
Postpartum depression symptoms can be debilitating and may include crying spells, difficulty bonding with your baby, inability to sleep or feelings of hopelessness. With severe postpartum depression, women are unable to function with daily routines and often have recurring thoughts of suicide, self-harm or harming the baby, which are very serious symptoms that require immediate evaluation and attention.
"We are committed to working with healthcare providers so women with PPD do not face this isolating condition alone," Alisha A. Alaimo, president of Biogen's North America Organization, said in the announcement. "We are proud to offer the first oral therapy indicated specifically for women with PPD and we hope this milestone adds to the growing efforts, federally and among health organizations, to improve maternal mental health care."
Biogen and Sage said Thursday that they have launched a patient support program called Zurzuvae For You that includes financial assistance, such as a copay assistance program, as well as medication at no cost for people who are eligible.
"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," Chris Benecchi, chief business officer at Sage Therapeutics, said in Thursday's announcement.
Other options to treat postpartum depression orally are selective serotonin reuptake inhibitors or SSRIs, antidepressants that "take weeks to kick in and must continue being taken on a daily basis for at least six to 12 months," Dr. Katrina Furey, a psychiatrist in private practice specializing in women's mental health and reproductive psychiatry, and a clinical instructor at Yale University, said in November.
The price of Zurzuvae seems especially high in comparison with those medicines, Furey said. SSRIs, which include the generic versions of drugs like Prozac and Zoloft, typically cost less than $20 a month, according to data from GoodRx.
"It remains to be seen how much insurance companies will cover it or if they will require women to 'fail' treatment with less-expensive SSRIs before paying for this new treatment," Furey said. "I hope that is not the case and that its price will not be a barrier to accessing this treatment."
She noted, though, that the $15,900 price tag is less than half that of an earlier postpartum depression drug from Sage called Zulresso. Priced at about $35,000, that drug is given via IV infusion over the course of 60 hours in a hospital.
CNN's Meg Tirrell contributed to this report.