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WASHINGTON (AP) — The first oral pill approved in the United States to treat postpartum depression is now available by prescription, according to drug makers.
The U.S. Food and Drug Administration approved the therapy, called Zurzuve, in August. The product, which is now in specialty pharmacies, can be shipped directly to patients, Biogen and Sage Therapeutics Inc. said in an announcement Thursday.
However, the drug will cost $15,900 per course before insurance, raising some concerns about how many people will be able to access it.
Zurzuve is given as two 25 mg capsules per day for 14 days to treat adults with postpartum depression or PPD, a serious mental illness that affects about 1 in 7 new mothers after childbirth. Can develop.
The drug makers noted that people taking Zurzuve in clinical trials had a greater reduction in their depressive symptoms than people taking a placebo, and the reduction was seen within three days and in the Phase 3 clinical study, for at least 45. It went on for days.
“An option like Zurzuve that can work on day 15 and improve symptoms in three days has the potential to make a profound difference in the lives of women with PPD,” said Dr. Christina Deligiannidis, a professor at the Feinstein Institutes. Medical Research in New York, which has been the principal investigator on the national multisite clinical trials that led to Zurzueva’s approval, the announcement said. “Hopefully this milestone is a catalyst for greater systemic change for women with PPD, including much-needed increases in screening, diagnosis, and treatment across all specialty physicians.”
Symptoms of postpartum depression can be debilitating and may include frequent crying, difficulty connecting 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, harming themselves, or harming the baby, which are very serious symptoms that require immediate evaluation and attention. Is required.
Alisha A., president of Biogen’s North America organization. “We are committed to working with health care providers so that women with PPD do not have to face this isolating situation alone,” Alamo said in the announcement. “We are proud to offer the first oral therapy specifically indicated for women with PPD and we hope this milestone will fuel growing efforts among federal and health organizations to improve maternal mental health care. “
Innovations are only effective when people can access them, and we will continue to support the goal of broad and equitable access.
-Chris Beneschi, Sage Therapeutics
Biogen and Sage said Thursday they have launched a patient assistance program called Zurzuve for You that includes financial assistance, such as a copay assistance program, as well as the drug at no cost to those who qualify.
“Innovations are only impactful if people can access them, and we will continue to support the goal of broad and equitable access. The goal of our support programs, where possible, is to help women with PPD who are diagnosed with PPD, Zurzuve said. “Provide the product at no cost to eligible patients without insurance because we believe “That lack of insurance or financial means should not be a barrier to access to treatment.”
Other options for orally treating postpartum depression are selective serotonin reuptake inhibitors, or SSRIs, antidepressants, “which take several weeks to take effect and must be taken on a daily basis for at least six to 12 months,” says Privat. Dr. Katrina Furey, a psychiatrist in practice specializing in women’s mental health and reproductive psychiatry and a clinical instructor at Yale University, said in November.
The cost of Zurzuve seems particularly high compared to those drugs, Fury said. According to data from GoodRx, SSRIs, which include generic versions of drugs like Prozac and Zoloft, typically cost less than $20 a month.
“It remains to be seen how much insurance companies will cover this or whether they will require women to have ‘failed’ treatment with less expensive SSRIs before they will pay for this new treatment,” Fury said. “I hope that is not the case and that the cost will not be a barrier to accessing this treatment.”
However, they noted that the $15,900 price is less than half that of Sage’s earlier postpartum depression drug called Zulresso. The drug, which costs about $35,000, is given through 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 with 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 on Lifeline 988
- The Trevor Project Hotline for LGBTQ teens: 1-866-488-7386
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