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