www.fdanews.com/articles/175495-trevena-gets-fda-breakthrough-therapy-designation-for-oliceridine
Trevena Gets FDA Breakthrough Therapy Designation for Oliceridine
February 26, 2016
King of Prussia, Pa.-based Trevena has scored a win at the FDA, with the agency granting it breakthrough therapy designation for intravenous oliceridine to manage moderate to severe acute pain.
Currently in Phase 3 development, oliceridine is eligible for FDA guidance on its development program — as well as rolling and priority review — as a result of the designation.
The FDA previously granted the candidate fast track designation.