FDA fast track designation to for Trevena's oliceridine for pain

4 December 2015

US GPCR ligand drug developer Trevena (Nasdaq: TRVN) says that the US Food and Drug Administration has granted fast track designation to oliceridine (TRV130) for the management of moderate-to-severe acute pain. The news caused Trevena’s share to rise 8% to $12.40 in after-hours trading on Thursday.

Oliceridine is being developed as a potential replacement for currently-approved intravenous opioid analgesics. In a recently completed Phase II study in postoperative pain, oliceridine matched the analgesic efficacy of morphine with an improved safety and tolerability profile. Trevena expects to initiate Phase III development of oliceridine in the first quarter of 2016.

“We believe that this fast track designation represents recognition by FDA of the significant unmet needs in the management of acute pain and of the potential for oliceridine to improve on current standards of care,” stated Maxine Gowen, chief executive officer.

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