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# Breakthrough Designation for Trevena Pain Drug
- URL: https://www.fdaweb.com/breakthrough-designation-for-trevena-pain-drug/
- Published: 2016-02-22T12:00:00.000Z
- Updated: 2026-09-15T02:38:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134842

> 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.