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WASHINGTON The first oral pill approved in the United States to treat postpartum depression is now available by prescription, according to the drug’s makers.
The US Food and Drug Administration approved the therapy, called Zurzuvae, in August. The product, now in specialty pharmacies, can be shipped directly to patients, Biogen and Sage Therapeutics Inc. said. in an announcement on Thursday.
However, the drug costs $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 giving birth.
Drugmakers noted that people taking Zurzuvae in clinical trials had greater reductions in their depressive symptoms compared to those taking a placebo, and the reductions were seen within three days and, at a Phase 3 clinical studies, lasting at least 45 days.
“Having an option like Zurzuvae that can work on Day 15 and improve symptoms as early as three days has the potential to make a huge difference in the lives of women with PPD,” Dr. Kristina Deligiannidis, a professor at the Feinstein Institutes for Medical Research in New York who was the principal investigator on the national multisite clinical trials that led to Zurzuvae’s approval, said in the announcement. “This milestone will hopefully be a catalyst for further systemic change for women with PPD including a much-needed increase in screening, diagnosis and treatment in physician specialties.”
Symptoms of postpartum depression can be debilitating and may include crying, difficulty bonding with your baby, inability to sleep or feelings of hopelessness. With severe postpartum depression, women are unable to function in daily activities and often have recurrent thoughts of suicide, harming themselves or harming the baby, which are very serious symptoms that require of immediate analysis and attention.
“We are committed to working with healthcare providers so that women with PPD do not face this isolated condition alone,” said Alisha A. Alaimo, president of Biogen’s North America Organization, in the announcement. “We are proud to offer the first oral therapy specifically indicated for women with PPD and we hope that this milestone adds to the growing efforts, federally and among health organizations, to improve health care of the mother’s mind.”
Innovations only have impact if people can access them, and we will continue to support the cause of broad and fair access.
–Chris Benecchi, Sage Therapeutics
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 free medication for people worthy.
“Innovations are only impactful if people can access them, and we will continue to support the cause of broad and fair access. Our support programs aim, where possible, to help women with PPD that prescribes Zurzuvae to have little to no copay, and to provide the product free of charge for eligible patients without insurance, because we believe that lack of insurance or financial means should not be a barrier in access to treatment,” Chris Benecchi, chief business officer at Sage Therapeutics, said in Thursday’s announcement.
Other options for treating postpartum depression orally are selective serotonin reuptake inhibitors or SSRIs, antidepressants that “start within a few weeks and should be continued to be taken daily for at least six to 12 months,” Dr. Katrina Furey, a psychiatrist in private practice. practice specializing in women’s mental health and reproductive psychiatry, and is a clinical instructor at Yale University, said in November.
Zurzuvae’s price seems especially high compared to those drugs, Furey said. SSRIs, which include 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 many insurance companies will cover this 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 access to this treatment.”
He noted, however, that the $15,900 price tag is less than half that of an earlier postpartum depression drug from Sage called Zulresso. At a price of about $35,000, that drug is given by IV infusion over 60 hours in a hospital.
Suicide prevention resources
If you or someone you know is struggling with suicidal thoughts, call 988 to connect to the 988 Suicide and Crisis Lifeline.
- Huntsman Mental Health Institute Crisis Line: 801-587-3000
- SafeUT Crisis Line: 833-372-3388
- 988 Suicide and Crisis LifeLine at 988
- Trevor Project Hotline for LGBTQ youth: 1-866-488-7386
Contributing: Meg Tyrrell
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