Postpartum depression affects 1 in every 9 mothers and it's largely misdiagnosed and treated
Sage Diagnostics finally got the positive nod from the Food and Drug Administration last Tuesday on their postpartum depression drug. ZulressoTM (brexanolone) will be administered as an injection for the treatment of postpartum depression (PPD). ZULRESSO is the first and only medicine specifically approved to treat PPD, the most common medical complication of childbirth and is expected to be available in late June following scheduling by the U.S. Drug Enforcement Administration, which is expected to occur within 90 days.
The approval is based on findings from three multicenter, randomized, double-blind, parallel-group, placebo-controlled trials, designed to evaluate the safety and effectiveness of the drug in women with moderate and severe PPD, aged between 18 and 45 years who were ≤6 months postpartum at screening and who had onset of symptoms no earlier than the third trimester and no later than the first four weeks following delivery.
In all trials at all doses, ZULRESSO achieved the primary endpoint, a significant mean reduction from baseline in the Hamilton Rating Scale for Depression (HAM-D) total score, a common measure of depression severity, at 60 hours compared to placebo. A reduction of depressive symptoms was also seen as early as 24 hours, and ZULRESSO maintained effect through the 30-day follow-up. The most common adverse events in the studies were sleepiness, dry mouth, loss of consciousness and flushing*.
The question about access to the forward thinking treatment still remains unanswered. The price tag sits today at a comfortable $34,000 per patient on average for a course of treatment, before discounts, according to the manufacturer. Additionally, the long term evolution of the treatment hasn't been proved yet - as the last follow up in the study was done on day 30 after administration.
While this achievement represents an advance in the quest for better maternal health and postpartum support, it is still important to consider the issue with maternal mental health from a holistic perspective, taking into consideration daily habits, genetics, and environmental factors that have a impact on a woman's overall mental wellbeing. It is paramount that we look into postpartum health as a process, and not as a subset of isolated health issues so we can provide comprehensive solutions to profiles that don't just fit xyz criteria - or can pay for expensive treatments.
** Sage Therapeutics Press release: https://investor.sagerx.com/news-releases/news-release-details/sage-therapeutics-announces-fda-approval-zulressotm-brexanolone