Oliceridine Granted Breakthrough Tx Status for Acute Pain
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.
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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