Breakthrough Designation for Trevena Pain Drug

FDA has granted Trevena a breakthrough therapy designation for intravenous TRV130 (oliceridine) for managing moderate-to-severe acute pain. The drug was designed to “optimize opioid receptor pharmacology to deliver an improved analgesic profile,” the company says. It is the “first receptor G protein pathway selective modulator (GPS) – a biased opioid receptor ligand that in preclinical studies activated pathways associated with analgesia while avoiding pathways that can promote respiratory depression and gastrointestinal dysfunction and limit analgesia,” it says.

In Phase 2 trials, oliceridine demonstrated rapid and powerful analgesic efficacy with reduced frequency of opioid-related adverse events, including nausea, vomiting, and hypoventilation compared to intravenous morphine, Trevena says. Currently, the drug is being studied in the ATHENA-1 safety and tolerability study. Phase 3 pivotal studies are expected to begin in the second quarter, it adds.