Track topics on Twitter Track topics that are important to you
CERC-301 is a novel potent and selective NR2B antagonist. It is a potential first-in-class, best-in-class, oral medication that is complimentary to existing treatments in depressed patients who have failed to respond to available therapies. CERC-301 has the potential to rapidly reduce depressive symptoms, including suicidality, in these severely affected patients. Patients and families who struggle with severe refractory depression and suicidality substantiate the need for more effective and more rapid acting treatments, and we will develop CERC-301 with the purpose that befits such an important unmet need. Current anti-depressant therapy is limited by modest response rates of ~60%, poor remission rates of ~35%, slow onset of action (~4-6 weeks) and problematic side effects including sexual dysfunction. There is an urgent need for a new treatment with a rapid onset of action for severely depressed/treatment resistant patients who may also be experiencing suicidality. Building on the results of a recently published exploratory study in severe, resistant depression by the National Institutes of Mental Health (“NIMH”), Cerecor has acquired exclusive, worldwide rights from Merck to develop and commercialize CERC-301, an orally acting NMDA receptor subunit 2B (NR2B) antagonist. There is a growing body of evidence to support the hypothesis that NMDA receptors are involved in the pathology of depression. NMDA channel blockers such as ketamine, as well as antagonists specific for NR2B, have recently been shown to provide rapid, profound improvement in patients with severe depression and suicidal ideation. These properties have been described as a potential ‘breakthrough’ in anti-depressant therapy by experts in the field. However, all drugs studied to date (excepting CERC-301) have required intravenous administration, and the use of ketamine has been limited by its unfavorable side-effects (hallucinations). An orally bioavailable drug that selectively targets the NR2B subunit of the NMDA receptor might provide rapid onset of profound antidepressant effects and yet allow for chronic treatment. Composition of matter patents on CERC-301 provide exclusivity until at least 2027.