Trevena announced that the Food and Drug Administration (FDA) has granted Fast Track designation to oliceridine (TRV130) for the management of moderate-to-severe acute pain.
Oliceridine is being developed as a potential replacement for currently approved intravenous opioid analgesics. It has been shown in a recently completed Phase 2b postoperative pain study, to be equally effective as morphine with improved safety and tolerability profile. Study data showed that oliceridine demonstrated comparable efficacy to a standard morphine regimen, with significantly lower incidence of nausea, vomiting, and hypoventilation. Trevena intends to initiate a Phase 3 trial for oliceridine in the first quarter of 2016.
Oliceridine (TRV130) is a biased mu-opioid receptor ligand.
The Fast Track program is designed to facilitate the development and review of drugs intended to treat serious conditions with unmet medical needs by providing sponsors with the opportunity for frequent interactions with the FDA.
For more information visit Trevenainc.com.