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The first oral drug approved in the United States to treat postpartum depression is now available by prescription, according to a drug company.
of U.S. Food and Drug Administration approves treatment, called Zurzvae in August. Biogen and Sage Therapeutics said the product, currently in specialty pharmacies, can be shipped directly to patients. announcement Thursday.
However, the drug Each course costs $15,900 Concerns have been raised about how many people have access to insurance before it becomes available.
Zulufly is administered at two 25-milligram capsules per day for 14 days to treat adults with postpartum depression or PPD, a serious mental illness that can occur in adults with: Approximately 1/7 New mothers after giving birth.
The drug companies found that in clinical trials, people who took Zipfly had greater reductions in depression symptoms than those who took a placebo, with reductions seen within three days and lasting at least 45 days in phase 3 clinical trials. he pointed out.
Professor Christina Deligiannidis of the Feinstein Institute said: “An option like Zulufly, which is effective from day 15 and can improve symptoms in as little as three days, could make a huge difference in the lives of women with PPD. There is a possibility.” New York Medical Research, the principal investigator of the national multicenter clinical trial that led to Zurzvae's approval, said in a statement. “We hope this milestone serves as a catalyst for more systemic change for women with PPD, including much-needed increases in screening, diagnosis and treatment across physician specialties.”
Symptoms of postpartum depression It can be debilitating and may cause you to cry constantly, have difficulty bonding with your baby, have trouble sleeping, and feel hopeless. With severe postpartum depression, women are unable to carry out daily activities and often have repeated thoughts of suicide, self-harm, or harm to their baby, which are very serious conditions that require immediate evaluation and attention. This is a serious symptom.
“We are committed to working with health care providers to ensure that no woman with PPD faces this isolation alone,” Alisha A. Alaimo, president of Biogen's North American organization, said in a statement. Stated. “We are proud to offer the first oral therapy specifically aimed at women with PPD. This milestone adds to the growing federal and health agency efforts to improve maternal mental health care. I hope we can connect.”
Biogen and Sage said on Thursday: They launched a patient assistance program called Zurzuvae For You. This includes financial assistance, such as co-pay assistance programs, and free medication for those eligible.
“Innovation is only impactful if people have access to it. We will continue to support the goal of broad and equitable access. Our assistance programs will ensure that where possible, prescription Our goal is to help women with PPD have little to no out-of-pocket costs and provide our products free to eligible uninsured patients because we believe there should be no lack of insurance or financial means. and create barriers to accessing treatment,” Chris Beneke, chief business officer of Sage Therapeutics, said in a statement Thursday.
Other options to treat postpartum depression orally include selective serotonin reuptake inhibitors, or SSRIs, drugs that “take several weeks to take effect and must be continued to be taken daily for at least 6 to 12 months.” It's a depressant. Dr. Katrina Furya practicing psychiatrist specializing in women's mental health and reproductive psychiatry and clinical instructor at Yale University. said in november.
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Furey said the price of the virus appears to be particularly high compared to those drugs. SSRIs include generic drugs like Prozac and Zoloft and typically cost less than $20 per month, according to GoodRx data.
“It remains to be seen how much insurance companies will cover, or if they will require women to 'fail' treatment with cheaper SSRIs before paying for this new treatment,” Fury said. “I hope that is not the case and that the price is not a deterrent to receiving this treatment.”
However, she noted that the $15,900 price tag is less than half the price of Sage's previous postpartum depression drug. Zullesso. It costs about $35,000 and is administered through an intravenous drip over a 60-hour period at the hospital.
CNN's Meg Tyrrell contributed to this report.
