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According to Drugmakers, the first postpartum depression medication is now available in the US.
CNN —
According to the manufacturers, the first oral medication authorized in the US for the treatment of postpartum depression is now available with a prescription.
In August, the Zurzuvae therapy received approval from the US Food and Drug Administration. Biogen and Sage Therapeutics Inc. announced on Thursday that patients can receive direct shipping of the product, which is currently available at specialty pharmacies.
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However, there are questions about how many people will be able to afford the medication given that it will cost $15,900 per course before insurance.
Zurzuvae is used to treat adults with postpartum depression (PPD), a serious mental illness that affects approximately 1 in 7 new mothers after giving birth. The medication is taken as two 25-milligram capsules per day for 14 days.
The manufacturers of the medication reported that in clinical trials, patients taking Zurzuvae experienced greater reductions in their depressive symptoms than patients receiving a placebo.
These reductions started to show up in three days and persisted for at least 45 days in a Phase 3 clinical study.
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According to Dr. Kristina Deligiannidis, a professor at the Feinstein Institutes for Medical Research in New York and the principal investigator of national multisite clinical trials that resulted in the approval of Zurzuvae,
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“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” said in the announcement.
“Hopefully, this accomplishment will serve as a springboard for additional systemic change for women with PPD, including a much-needed rise in screening, diagnosis, and care across medical specialties.”
The symptoms of postpartum depression can be crippling and include feeling hopeless, inability to sleep, difficulty bonding with your baby, and crying fits.
Women who suffer from severe postpartum depression find it difficult to go about their everyday lives and frequently have thoughts of suicide, self-harm, or harming the unborn child. These are extremely serious symptoms that need to be evaluated right away.
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The announcement quoted Alisha A. Alaimo, president of Biogen’s North America Organization, as saying, “We are committed to working with healthcare providers so women with PPD do not face this isolating condition alone.”
We hope that this significant achievement will contribute to the increasing efforts being made by health organizations and the federal government to enhance maternal mental health care.
We are proud to provide the first oral therapy recommended specifically for women with PPD.
Zurzuvae For You is a patient support program that Biogen and Sage announced on Thursday. It offers free medication to qualified individuals as well as financial aid, such as a copay assistance program.
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We will keep promoting the objective of widespread and equitable access because innovations can only have a significant impact if people can use them.
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When women with PPD are prescribed Zurzuvae, our support programs try to make it as easy as possible for them to have little to no copay and to offer
product at no cost for qualified patients without insurance, since we feel that access to treatment shouldn’t be impeded by a patient’s inability to pay or obtain insurance,”
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Sage Therapeutics Chief Business Officer Chris Benecchi stated in the company’s announcement on Thursday.
Selective serotonin reuptake inhibitors, or SSRIs, are another option for treating postpartum depression orally. These antidepressants “take weeks to kick in and must continue being taken on a daily basis for at least six to 12 months,” according to Dr.
Katrina Furey, a clinical instructor at Yale University and a private practice psychiatrist who specializes in women’s mental health and reproductive psychiatry. She made this statement in November.
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According to Furey, the cost of Zurzuvae appears disproportionately high when compared to those medications. According to data from GoodRx, SSRIs, which include generic versions of medications like Prozac and Zoloft, usually cost less than $20 per month.
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“How much insurance companies will pay for it is still to be determined, as is whether they will make women ‘fail’ treatment with less expensive SSRIs before funding this new treatment,” Furey stated.
“I hope that’s not the case and that the cost won’t prevent people from using this treatment.”
However, she pointed out that the $15,900 price tag is less than half of what Sage charged for Zulresso, an earlier medication for postpartum depression.
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That medication, which costs roughly $35,000, is administered via IV infusion over a 60-hour period in a hospital.
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