FDA approves new opioid analgesic for intravenous (IV) use in hospitals or other controlled clinical settings

August 13, 2020 · Optum Workers' Comp and Auto No-fault

A new injectable opioid analgesic, Olinvyk™ (oliceridine), was approved by the U.S. Food and Drug Administration (FDA) on August 7, 2020. Olinvyk is indicated to manage acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. Marketed by Trevena Inc., this opioid analgesic is for short-term use in a controlled clinical setting, meaning under medical supervision in a hospital and during inpatient and outpatient procedures. It is not indicated for at-home use.

Impact on workers’ compensation and auto no-fault

Because Olinvyk injection is not for use as a take-home prescription, we do not expect this medication to be dispensed at a retail or home delivery pharmacy for claimants.

Olinvyk will be reviewed by our Pharmacy and Therapeutics Committee to determine its status on all of our standard formularies where opioid analgesics are allowed.

General recommendations for use and availability

Olinvyk is an opioid agonist with the same safety profile, abuse potential and risks from concurrent use with benzodiazepines and other central nervous system (CNS) depressants as other opioid analgesics, such as morphine sulfate. Olinvyk has a maximum recommended daily dose limit of 27 mg. According to Trevena, Olinvyk is expected to become available in the fourth quarter of 2020 after the U.S. Drug Enforcement Administration (DEA) issues its controlled substance schedule.

For more detailed information on Olinvyk, please click here.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Source:

U.S. Food and Drug Administration (FDA). News & Events. Newsroom. Press Announcements. FDA News Release. FDA Approves New Opioid for Intravenous Use in Hospitals, Other Controlled Clinical Settings. August 7, 2020. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-new-opioid-intravenous-use-hospitals-other-controlled-clinical-settings.