Exhibit 99.1
Sage Therapeutics Announces U.S. Drug Enforcement Administration Scheduling of ZULRESSO™ (brexanolone) Injection
On track for full commercial launch in the U.S. in late June
CAMBRIDGE, Mass., June 14, 2019 – Sage Therapeutics (NASDAQ: SAGE), a biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that the U.S. Drug Enforcement Administration (DEA) has placed ZULRESSO™ (brexanolone) injection into Schedule IV of the Controlled Substances Act. ZULRESSO, which was approved by the U.S. Food and Drug Administration (FDA) on March 19, 2019, is the first and only treatment specifically approved for postpartum depression (PPD), the most common medical complication of childbirth.
With this decision, the product label for ZULRESSO will be finalized. The Company expects to launch ZULRESSO in late June as planned. ZULRESSO is administered via continuous intravenous (IV) infusion for 2.5 days under the supervision of healthcare providers in sites of care certified under the ZULRESSO Risk Evaluation and Mitigation Strategy (REMS) program. The one-time infusion offers the potential for rapid resolution of depressive symptoms of PPD.
“Historically, women suffering from PPD may have avoided seeking help because of the stigma, lack of a specifically approved treatment and the complicated journey to care – challenges that have been difficult for women with PPD and their families to overcome,” said Mike Cloonan, chief business officer at Sage. “Sage is taking on those challenges and creating a family-centric approach to ZULRESSO availability by enabling pathways to care including building our patient support organization, where we will provide a range of meaningful support resources to women with PPD and their families to help navigate the ZULRESSO treatment journey. We also continue to activate Centers of Excellence across the country with the goal of supporting a positive patient experience and broad availability to ZULRESSO for women with PPD.”
The Company continues to focus on identifying and activating Centers of Excellence (COE) and other healthcare settings capable of administering ZULRESSO to women with PPD. The key criteria for identifying a potential COE or other sites of care include: a PPD healthcare provider champion; the ability to secure appropriate payer reimbursement for ZULRESSO; and the capability to meet the requirements for certification under the ZULRESSO REMS, which includes monitoring by qualified trained staff, adherence to specific protocols and the maintenance of a patient registry. The Company continues to execute against its plannedgo-to-market strategy with a focus on the commercial launch of ZULRESSO in late June.
For more information on ZULRESSO, including the final product label, visit www.sagerx.com.
About Postpartum Depression
Postpartum depression (PPD) is the most common medical complication of childbirth. PPD is a distinct and readily identified major depressive episode that can occur during pregnancy or after giving birth. Expert opinions vary as to the timing of the onset of PPD, ranging from onset during pregnancy up to4-weeks postpartum and onset during pregnancy up to12-months postpartum. PPD may have devastating consequences for a woman and for her family, which may include significant functional impairment, depressed mood and/or loss of interest in her newborn, and associated symptoms of depression such as loss of appetite, difficulty sleeping, motor challenges, lack of concentration, loss of energy and poor self-esteem. PPD can be a life-threatening condition due to the risk of suicide, a leading cause of maternal death following childbirth. PPD is estimated to affect approximately one in nine women who have given birth in the U.S. and 400,000 women annually. More than half of these cases may go undiagnosed without proper screening.
