CNS biopharma company Sage Therapeutics is all set to commercially launch its ZULRESSO (brexanolone) injection in the US later this month for the treatment of postpartum depression (PPD), a major depressive episode that can occur during pregnancy or after delivery.
Sage Therapeutics said that the US Drug Enforcement Administration (DEA) has put ZULRESSO into Schedule IV of the Controlled Substances Act. The drug, which is a positive allosteric modulator of both synaptic and extrasynaptic GABAA receptors, was approved by the US Food and Drug Administration (FDA) in March 2019.
ZULRESSO is to be administered under the supervision of healthcare providers to the patient through continuous intravenous (IV) infusion for 2.5 days. The one-time infusion is said to provide the potential for quick resolution of depressive symptoms of postpartum depression.
Mike Cloonan – chief business officer at Sage Therapeutics said: “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.
“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.”