23/02/2024

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New Oral PPD Treatment Zuranolone Will Soon Hit the Market as Zurzuvae

New Oral PPD Treatment Zuranolone Will Soon Hit the Market as Zurzuvae

A few months ago, the Food and Drug Administration approved zuranolone, the first oral medication for the treatment of postpartum depression.  Zuranolone will be marketed under the brand name Zurzuvae by Sage Therapeutics in partnership with Biogen and is expected to be available later this year. On November 7, 2023, Sage Therapeutics announced that the wholesale cost of the postpartum depression drug would be $15,900 for a 14-day treatment cycle.

The goal of broad affordable access for women with PPD who are 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 two companies are working to enable women with PPD who are prescribed ZURZUVAE to be able to access treatment with minimal restrictions and, where possible, with little to no co-pay regardless of financial means. To this end, Sage and Biogen are actively engaged with national, regional and government payors. The companies are also planning to help women with PPD through patient support programs that provide PPD education, as well as financial assistance for eligible patients prescribed ZURZUVAE to help cover costs, or free drug, and other support.

As an oral, once-daily, 14-day treatment that can provide rapid improvements in depressive symptoms by Day 15 and as early as Day 3, zuranolone provides women  with a new option for the treatment of PPD.  Although traditional antidepressants, including the selective serotonin and serotonin-norepinephrine reuptake inhibitors (SSRIs and SNRIs), are not specifically approved by the FDA for the treatment of PPD, they are effective in this setting.  The real advantage of zuranolone is that it starts to work much earlier than typical antidepressants, which can take 2-4 weeks to elicit significant improvements in depressive symptoms.  

Zuranolone is generally well-tolerated.  The most common adverse events are somnolence, dizziness, and sedation. No loss of consciousness, withdrawal symptoms, or increased suicidal ideation or behavior were observed.

Who Will Have Access to Zuranolone?

Zuranolone would represent a new option for the treatment of PPD, a rapidly acting antidepressant with a good safety profile.  However, zuranolone may not be the first choice for every women.  

Although the manufacturers of zuranolone are working with insurance payors to ensure access to zuranolone, this may 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.  (According to GoodRx, a 6-month course of fluoxetine costs about $32 at Walmart.)

In addition, we do not have any information on the use of zuranolone in breastfeeding women.   Participants in the zuranolone clinical trials were asked to forgo breastfeeding while taking zuranolone.  We do not yet have information regarding the secretion of zuranolone into the breast milk or the effects of zuranolone found in the breast milk on the nursing infant.  Nor do we know if zuranolone affects breast milk production.   For many women, having to interrupt or avoid breastfeeding while receiving treatment for PPD may be a significant deterrent.

Although further study is required and zuranolone may not represent a first-line treatment for all women with PPD, there are many women who will benefit from having another treatment option, including women with severe symptoms or suicidal ideation and those unable to tolerate traditional antidepressant treatments.

Ruta Nonacs, MD PhD

 

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