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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.