What is ZULRESSO?
ZULRESSO is the first medicine specifically approved by the U.S. Food and Drug Administration to treat PPD in adults. It was approved by the FDA in March 2019. ZULRESSO is only available
through the ZULRESSO Risk Evaluation and Mitigation Strategy (REMS), a safety program to manage the risk of serious harm resulting from excessive sedation and sudden loss of consciousness
during the ZULRESSO infusion. To administer ZULRESSO, sites of care must be certified in the ZULRESSO REMS.
OCH is certified under the ZULRESSO REMS. ZULRESSO is administered via continuous intravenous (IV) infusion into the vein for a total of 60 hours (2.5 days), and women must be under the
supervision of trained healthcare providers for the duration of the infusion.
In clinical trials, 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 at the 30-day follow-up. The most common adverse events in the studies were sleepiness,
dry mouth, loss of consciousness and flushing of the skin or face.