A couple of months in the past, the Meals and Drug Administration accepted zuranolone, the primary oral medicine for the remedy of postpartum melancholy. Zuranolone will probably be marketed underneath the model identify Zurzuvae by Sage Therapeutics in partnership with Biogen and is anticipated to be accessible later this yr. On November 7, 2023, Sage Therapeutics announced that the wholesale value of the postpartum melancholy drug can be $15,900 for a 14-day remedy cycle.
The objective of broad inexpensive entry for ladies 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 remedy course. The 2 corporations are working to allow girls with PPD who’re prescribed ZURZUVAE to have the ability to entry remedy with minimal restrictions and, the place potential, 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 via affected person help applications that present PPD training, 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 remedy 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 remedy of PPD. Though conventional antidepressants, together with the selective serotonin and serotonin-norepinephrine reuptake inhibitors (SSRIs and SNRIs), are usually not particularly accepted by the FDA for the remedy 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 most typical 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 characterize a brand new possibility for the remedy of PPD, a quickly appearing antidepressant with a very good security profile. Nevertheless, zuranolone is probably not the primary selection for each girls.
Though the producers of zuranolone are working with insurance coverage payors to make sure entry to zuranolone, this will likely take time. With a 16K price ticket for a 14-day course of remedy, insurers and Medicaid could restrict entry to zuranolone by requiring sufferers to strive different antidepressants first. (In keeping with GoodRx, a 6-month course of fluoxetine prices about $32 at Walmart.)
As well as, we don’t have any info on the usage of zuranolone in breastfeeding girls. Members within the zuranolone scientific trials had been requested to forgo breastfeeding whereas taking zuranolone. We don’t but have info concerning the secretion of zuranolone into the breast milk or the consequences 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 remedy for PPD could also be a big deterrent.
Though additional research is required and zuranolone could not characterize a first-line remedy for all girls with PPD, there are various girls who will profit from having one other remedy possibility, together with girls with extreme signs or suicidal ideation and people unable to tolerate conventional antidepressant remedies.
Ruta Nonacs, MD PhD
