Sage is focused on developing transformative medicines, and bringing hope for conditions with limited treatment options.
Our proprietary compounds target the GABA and NMDA receptor systems, critical regulators of nerve signaling in the brain. Dysfunction in these systems is known to be at the core of numerous disorders.
Our lead program, a proprietary IV formulation of brexanolone, has completed Phase 3 clinical development for postpartum depression and a New Drug Application is currently under review with the U.S. Food and Drug Administration. We are developing next generation modulators, including SAGE-217 and SAGE-718, in various CNS disorders.
Postpartum depression is the most common medical complication of childbirth that is estimated to affect 8-20% of new mothers in the U.S., varying by state with an overall average of 11.5%. During pregnancy, levels of certain hormones rise and then rapidly fall after giving birth. These hormone shifts may put some women at risk for developing postpartum depression.
Postpartum depression 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. There is no FDA-approved therapy specifically for postpartum depression.
Our Phase 3 Robin Study is a pivotal trial evaluating the safety and effectiveness of SAGE-217 in women with postpartum depression.
Major depressive disorder is a common but serious mood disorder, often affecting how a person feels, thinks, and handles daily activities. Approximately 16 million people in the U.S. suffer from major depression each year. While antidepressants are widely used for treatment, results from large scale studies suggest the need for additional options.
GABA modulation is being explored as a different mechanism of action for treating major depressive disorder. Sage is testing SAGE-217 as an oral therapy for this disorder.