Major Depressive Disorder Candidate Gets Fast Track from FDA
Cerecor announced that the FDA has granted Fast Track designation to its lead clinical product candidate, CERC-301 for major depressive disorder (MDD). CERC-301 is a once daily, oral, adjunctive, selective NMDA receptor subunit 2B (NR2B) antagonist with the potential to be the first in a new class of rapidly-acting antidepressants.
Cerecor had recently announced the initiation of a Phase 2 clinical study of CERC-301 as an adjunctive treatment for subjects with MDD who have not adequately responded to their current therapy and report recent suicidal ideation. The 135 patient, placebo-controlled Phase 2 study is designed with input from a panel of clinical experts in the treatment of depression to assess CERC-301 as adjunctive treatment. The study population consists of MDD subjects who would likely benefit most from rapid onset antidepressant activity - those who are failing current selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) treatment, have had recent active suicidal ideation, and are deemed appropriate for an out-patient study with careful safety surveillance.For more information call (410) 522-8707 or visit Cerecor.com.