A couple of months in the past, the Meals and Drug Administration authorized zuranolone, the primary oral remedy for the therapy of postpartum despair. Zuranolone will likely be marketed underneath the model identify Zurzuvae by Sage Therapeutics in partnership with Biogen and is predicted to be out there later this 12 months. On November 7, 2023, Sage Therapeutics introduced that the wholesale value of the postpartum despair drug can be $15,900 for a 14-day therapy cycle.
The objective of broad inexpensive entry for girls with PPD who’re prescribed ZURZUVAE has been a key consideration for Sage and Biogen in setting the deliberate wholesale acquisition value of $15,900 for a full 14-day therapy course. The 2 corporations are working to allow girls with PPD who’re prescribed ZURZUVAE to have the ability to entry therapy with minimal restrictions and, the place doable, with little to no co-pay no matter monetary means. To this finish, Sage and Biogen are actively engaged with nationwide, regional and authorities payors. The businesses are additionally planning to assist girls with PPD by way of affected person help packages that present PPD schooling, in addition to monetary help for eligible sufferers prescribed ZURZUVAE to assist cowl prices, or free drug, and different help.
As an oral, once-daily, 14-day therapy that may present speedy enhancements in depressive signs by Day 15 and as early as Day 3, zuranolone supplies girls with a brand new possibility for the therapy of PPD. Though conventional antidepressants, together with the selective serotonin and serotonin-norepinephrine reuptake inhibitors (SSRIs and SNRIs), are usually not particularly authorized by the FDA for the therapy of PPD, they’re efficient on this setting. The true benefit of zuranolone is that it begins to work a lot sooner than typical antidepressants, which might take 2-4 weeks to elicit important enhancements in depressive signs.
Zuranolone is mostly well-tolerated. The commonest adversarial occasions are somnolence, dizziness, and sedation. No lack of consciousness, withdrawal signs, or elevated suicidal ideation or conduct had been noticed.
Who Will Have Entry to Zuranolone?
Zuranolone would signify a brand new possibility for the therapy of PPD, a quickly performing antidepressant with a very good security profile. Nevertheless, zuranolone will not be the primary selection for each girls.
Though the producers of zuranolone are working with insurance coverage payors to make sure entry to zuranolone, this may increasingly take time. With a 16K price ticket for a 14-day course of therapy, insurers and Medicaid could restrict entry to zuranolone by requiring sufferers to strive different antidepressants first. (In response to GoodRx, a 6-month course of fluoxetine prices about $32 at Walmart.)
As well as, we don’t have any data on the usage of zuranolone in breastfeeding girls. Contributors within the zuranolone medical trials had been requested to forgo breastfeeding whereas taking zuranolone. We don’t but have data relating to the secretion of zuranolone into the breast milk or the results of zuranolone discovered within the breast milk on the nursing toddler. Nor do we all know if zuranolone impacts breast milk manufacturing. For a lot of girls, having to interrupt or keep away from breastfeeding whereas receiving therapy for PPD could also be a major deterrent.
Though additional research is required and zuranolone could not signify a first-line therapy for all girls with PPD, there are various girls who will profit from having one other therapy possibility, together with girls with extreme signs or suicidal ideation and people unable to tolerate conventional antidepressant therapies.
Ruta Nonacs, MD PhD
