The Food and Drug Administration approved the primary oral medication for the treatment of postpartum depression. Zuranolone might be marketed under the brand name Zurzuvae by Sage Therapeutics in partnership with Biogen and is anticipated to be available after the Drug Enforcement Administration completes a 90-day review. No information was provided regarding the value of the medication.
We now have been talking about zuranolone for some time and are eagerly awaiting its arrival. Zuranolone is analogous to brexanolone, which was approved in 2019 by the FDA for the treatment of PPD. Like brexanolone, zuranolone is a neuroactive steroid with antidepressant activity and a novel mechanism of motion as positive allosteric modulators of GABA-A receptors. The large difference between the 2 is that zuranolone is out there as a pill, while brexanolone is run as an intravenous infusion. This can be a huge advantage with regards to ease of use and accessibility.
To date there have been several randomized controlled trials supporting the efficacy of zuranolone for the treatment of postpartum depression (PPD). In probably the most recent study, a double-blind phase 3 trial published within the American Journal of Psychiatry, women with severe PPD were randomized to receive zuranolone (50 mg/day) or placebo for 14 days. Zuranolone was superior to placebo starting at day 3, and this trend was observed at every subsequent study visit.
Although traditional antidepressants, including the selective serotonin and serotonin-norepinephrine reuptake inhibitors (SSRIs and SNRIs), aren’t specifically approved by the FDA for the treatment of PPD, they’re effective on this setting. The true advantage of zuranolone is that it starts to work a lot sooner than typical antidepressants, which might take 2-4 weeks to elicit significant improvements in depressive symptoms.
Zuranolone is mostly well-tolerated. Probably the most common hostile events are somnolence, dizziness, and sedation. No lack of consciousness, withdrawal symptoms, or increased suicidal ideation or behavior were observed.
Who’s a Good Candidate for Zuranolone?
Zuranolone would represent a brand new option for the treatment of PPD, a rapidly acting antidepressant with an excellent safety profile. Nevertheless, zuranolone might not be the primary selection for each women.
At this point, we would not have any information on using 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 consequences 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.
As well as, women who’ve histories of recurrent depression and have responded well to a selected medication up to now may decide to return to that medication somewhat than try zuranolone for the primary time.
Although further study is required and zuranolone may not represent a first-line treatment for all women with PPD, there are a lot of women who will profit from having one other treatment option, including women with severe symptoms or suicidal ideation and people unable to access long-term psychiatric care.
Ruta Nonacs, MD PhD
For the First Time, There’s a Pill for Postpartum Depression (Recent York Times)