There is a significant unmet medical need for rapidly acting treatment of subjects with
severe major depressive disorder (MDD) who have not adequately responded to antidepressant
therapy. Alternative therapies require weeks to achieve full efficacy, may have significant
side effects, and still fail in a high percentage of subjects. Rapid reduction of severe
depression by pharmacological therapy is important to reduce the need for hospitalization and
risk of self-harm and mortality. CERC-301, a highly selective, orally bioavailable,
N-methyl-D-aspartate (NMDA) receptor subunit 2B (NR2B), also referred to as Glutamate NMDA
receptor subunit epsilon-2 (GluN2B) antagonist, would be a therapeutic breakthrough if it
provides rapid onset of antidepressant effects and an effect size similar to that seen with
experimental intravenous NMDA modulators.