- Trevena (NASDAQ:TRVN) is up 9% premarket on average volume in response to the company's announcement of detailed results from two Phase 3 studies, APOLLO-1 and APOLLO-2, assessing analgesic candidate OLINVO (oliceridine injection) for the management of moderate-to-severe acute pain in a hospital setting. The data were presented at the 42nd Annual Regional Anesthesiology and Acute Pain Medicine Meeting in San Francisco hosted by the American Society of Regional Anesthesia and Pain Medicine.
- Both studies met their primary efficacy endpoints compared to placebo but failed to consistently demonstrate statistically valid reductions in side effects compared to morphine (0.35 mg and 0.5 mg doses). The 0.1 mg dose showed significantly lower rates of unwanted side effects but failed to achieve non-inferiority with morphine. In other words, the lowest dose was better tolerated but did not relieve pain as well.
- In February, shares cratered over 30% after the company first reported the results. Investors hit the sell buttons over apparent disappointment with safety and side effect data.
- Oliceridine, a G-protein-biased ligand that targets the mu opioid receptor, is being developed as a potential replacement of intravenous opioid analgesics. Its value proposition is comparable pain relieving efficacy to morphine while minimizing the unwanted respiratory depression, GI dysfunction (constipation), nausea and vomiting.
- Previously: Trevena reports positive late-stage results for opioid substitute oliceridine; safety/side effect data underwhelm; shares slump 32% premarket (Feb. 21)
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