Trevena announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to intravenous oliceridine (TRV130) for the management of moderate-to-severe acute pain.
Oliceridine is currently in Phase 3 development after two successful Phase 2 studies which demonstrated rapid and potent analgesia with reduced frequency of opioid-related adverse events (eg, nausea, vomiting, hypoventilation) compared to intravenous morphine. ATHENA-1, a safety and tolerability study, is ongoing and other pivotal studies are expected to commence in the second quarter of 2016.
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Oliceridine is the first μ receptor G protein pathway selective modulator (μGPS), a biased μ opioid receptor ligand designed to activate pathways associated with analgesia while avoiding those that can promote respiratory depression and gastrointestinal dysfunction.
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