OCH is certified to administer ZULRESSO for the treatment of postpartum depression (PPD) in adults under the ZULRESSO Risk Evaluation and Mitigation Strategy (REMS).
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.
How can I learn more?
For more information on ZULRESSO, please refer to the Prescribing Information and Medication Guide on the FDA website. For additional information on the PPD services offered at OCH please call Michelle Hickerson, RN, Director of Patient Access & ZULRESSO Liason (270-298-5158). To schedule an appointment directly with Dr. Ottman, Board Certified Gynecologist, please call 270-730-5344. You can also contact Sage Central, Sage Therapeutics’ patient support program, at 1-844-4-SAGERX (1-844-472-4379) or visit SageCentralSupport.com for information on other patient support resources and programs for women with PPD and their families.