Just a few months ago, the Food and Drug Administration approved zuranolone, the primary oral medication for the treatment of postpartum depression. Zuranolone can be marketed under the brand name Zurzuvae by Sage Therapeutics in partnership with Biogen and is predicted to be available later this 12 months. On November 7, 2023, Sage Therapeutics announced that the wholesale cost of the postpartum depression drug can be $15,900 for a 14-day treatment cycle.
The goal of broad inexpensive access for ladies with PPD who’re prescribed ZURZUVAE has been a key consideration for Sage and Biogen in setting the planned wholesale acquisition cost of $15,900 for a full 14-day treatment course. The 2 corporations are working to enable women with PPD who’re prescribed ZURZUVAE to have the ability to access treatment with minimal restrictions and, where possible, with little to no co-pay regardless of monetary means. To this end, Sage and Biogen are actively engaged with national, regional and government payors. The businesses are also planning to assist women with PPD through patient support programs that provide PPD education, in addition to financial assistance for eligible patients prescribed ZURZUVAE to assist cover costs, or free drug, and other support.
As an oral, once-daily, 14-day treatment that may provide rapid improvements in depressive symptoms by Day 15 and as early as Day 3, zuranolone provides women with a brand new option for the treatment of PPD. Although traditional antidepressants, including the selective serotonin and serotonin-norepinephrine reuptake inhibitors (SSRIs and SNRIs), will not be specifically approved by the FDA for the treatment of PPD, they’re effective on this setting. The actual advantage of zuranolone is that it starts to work much sooner than typical antidepressants, which might take 2-4 weeks to elicit significant improvements in depressive symptoms.
Zuranolone is usually well-tolerated. Probably the most common antagonistic events are somnolence, dizziness, and sedation. No lack of consciousness, withdrawal symptoms, or increased suicidal ideation or behavior were observed.
Who Will Have Access to Zuranolone?
Zuranolone would represent a brand new option for the treatment of PPD, a rapidly acting antidepressant with a very good safety profile. Nevertheless, zuranolone is probably not the primary selection for each women.
Although the manufacturers of zuranolone are working with insurance payors to make sure access to zuranolone, this will take time. With a 16K price tag for a 14-day course of treatment, insurers and Medicaid may limit access to zuranolone by requiring patients to try other antidepressants first. (In line with GoodRx, a 6-month course of fluoxetine costs about $32 at Walmart.)
As well as, we shouldn’t have any information on the usage of zuranolone in breastfeeding women. Participants within the zuranolone clinical trials were asked to forgo breastfeeding while taking zuranolone. We don’t yet have information regarding the secretion of zuranolone into the breast milk or the results of zuranolone present in the breast milk on the nursing infant. Nor can we know if zuranolone affects breast milk production. For many ladies, having to interrupt or avoid breastfeeding while receiving treatment for PPD could also be a major deterrent.
Although further study is required and zuranolone may not represent a first-line treatment for all women with PPD, there are lots of women who will profit from having one other treatment option, including women with severe symptoms or suicidal ideation and people unable to tolerate traditional antidepressant treatments.
Ruta Nonacs, MD PhD