The first drug for postpartum depression is now available in the U.S., says drugmaker CNN



CNN

The first oral drug approved in the United States to treat postpartum depression is now available by prescription, according to the drugmaker.

The U.S. Food and Drug Administration approved the treatment, Zurzuvae, in August. Biogen and Sage Therapeutics Inc. said in statements Thursday that the product is now available in specialty pharmacies and can also be shipped directly to patients.

However, the drug costs $15,900 per course before insurance, raising concerns among some about how many people will be able to access it.

Zurzuvae, taken as two 25 mg capsules daily for 14 days, is used to treat adults suffering from postpartum depression, or postpartum depression, a serious mental illness that affects about one in seven new mothers after giving birth. It is possible to develop this disease.

The pharmaceutical company pointed out that people who took Zurzuvae in clinical trials experienced greater reductions in depressive symptoms than those who took placebo, and this reduction was visible within three days. In a Phase 3 clinical study, This relief lasted for at least 45 days.

Options like Zurzuvae, which works as early as day 15 and improves symptoms as early as three days, have the potential to have a profound impact on the lives of women with PPD, said Dr. Kristina Deligiannidis, a professor at the Feinstein Institute for Medical Research in New York. York said in the announcement that he was the principal investigator on the national multicenter clinical trial that led to Zurzuvaes’ approval. This milestone will hopefully serve as a catalyst for more systemic changes for women suffering from postpartum depression, including much-needed increases in screening, diagnosis and treatment across physician specialties.

Symptoms of postpartum depression can be debilitating and may include crying, difficulty connecting with your baby, being unable to sleep, or feeling hopeless. Women with severe postpartum depression are unable to carry out daily activities and often experience recurring thoughts of suicide, self-harm, or harming their baby. These are very serious symptoms that require immediate evaluation and attention.

Alisha A. Alaimo, president of Biogens’ North American organization, said in a statement, “We are committed to working with health care providers so that women suffering from postpartum depression do not face this isolating condition alone. We are proud to offer the first oral treatment specifically for women with postpartum depression, and we hope this milestone will advance ongoing efforts by federal and health organizations to improve maternal mental health care.

Biogen and Sage said Thursday They have launched a patient support program called “Zurzuvae For You,” which includes financial assistance such as a copay assistance program and free medication for those who qualify.

Innovation will only have an impact if people have access to it, and we will continue to support the goal of broad and equitable access to innovation. Our support program is designed to help women with postpartum depression who are prescribed Zurzuvae at virtually no out-of-pocket cost as much as possible, and provides the product at no cost to eligible patients who do not have insurance because we believe a lack of insurance or financial means should not be a problem. Sage Therapeutics Chief Commercial officer Chris Benecchi said in a statement on Thursday that this would act as a barrier to accessing treatment.

Dr. Katrina Furey, a psychiatrist in private practice, says other oral options for treating postpartum depression are selective serotonin reuptake inhibitors, or SSRIs. These antidepressant drugs take several weeks to work and must be taken at least six to six times a day. 12 months. , a clinical lecturer in women’s mental health and reproductive psychiatry at Yale University, said last November.

Furey said Zurzuvae’s price seemed particularly high compared with those drugs. SSRIs, including generics like Prozac and Zoloft, typically cost less than $20 per month, according to GoodRx.

Furey said it remains to be seen how much insurance companies will cover, or whether they will require women to pay for the new treatment only after they fail treatment with less expensive SSRIs. I hope this is not the case and the price is not a barrier to accessing this treatment.

However, she points out that the $15,900 price tag is less than half the price of Zulresso, an early postpartum depression drug produced by Sage. The drug, which costs about $35,000, is infused intravenously in a hospital for 60 hours.

CNN’s Meg Tirrell contributed to this report.

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