FDAnews
www.fdanews.com/articles/174415-fda-fast-tracks-trevenas-pain-candidate

FDA Fast Tracks Trevena’s Pain Candidate

December 9, 2015

King of Prussia, Pa.-based Trevena has scored a win at the FDA, which granted the company fast track status for oliceridine to manage moderate-to-severe acute pain.

If approved, oliceridine is intended to serve as a replacement for intravenous opioid analgesics. The company is planning to start Phase 3 studies early next year after the candidate matched the analgesic efficacy of morphine in a Phase 2 trial in postoperative pain.

In previous studies, oliceridine delivered pain relief safely and rapidly versus IV morphine.  Trevena develops biased ligands targeting G protein coupled receptors.