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# FDA OK’s Intravenous Opioid for Pain
- URL: https://www.fdaweb.com/fda-oks-intravenous-opioid-for-pain/
- Published: 2020-08-10T12:00:00.000Z
- Updated: 2026-09-14T16:24:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147392

FDA has approved a Trevena NDA for Olinvyk (oliceridine), an opioid agonist for managing moderate to severe acute pain in adults when the pain is severe enough to require an intravenous opioid and alternative treatments are inadequate. The drug is indicated for short-term intravenous use in hospitals or other controlled clinical settings (inpatient and outpatient procedures). Approval was based on data from 1,535 patients with moderate to severe acute pain who were treated with Olinvyk in controlled and open-label trials, an FDA [news release](https://www.fda.gov/news-events/press-announcements/fda-approves-new-opioid-intravenous-use-hospitals-other-controlled-clinical-settings?utm%5Fcampaign=FDA%20approves%20new%20opioid%20for%20short-term%20intravenous%20use&utm%5Fmedium=email&utm%5Fsource=Eloqua) says. “Its safety and efficacy were established by comparing Olinvyk to placebo in randomized, controlled studies of patients who had undergone bunion surgery or abdominal surgery,” it says. “Patients administered Olinvyk reported decreased pain compared to placebo at the approved doses.”

Olinvyk carries a boxed warning about addiction, abuse and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; and risks from concomitant use with benzodiazepines or other central nervous system depressants, the agency notes. Unlike other opioids for intravenous administration, Olinvyk has a maximum recommended daily dose limit of 27 mg.