Cerecor’s Depressive Disorder Drug Gains Fast Track

Cerecor was granted Fast Track designation by the FDA for 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.

The FDA’s Fast Track Drug Development Program is designed to facilitate the clinical development and expedite the review of drugs intended to treat a serious or life-threatening condition, which demonstrate the potential to address an unmet medical need.

Cerecor recently initiated a Phase II 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.