FDA Approves New Intravenous Opioid

The US Food and Drug Administration have approved Olinvyk (oliceridine), for the management of severe acute pain in adults for whom intravenous opioid use is required.

The new drug is indicated for short-term use only in controlled clinical environments.

The safety and effectiveness of Olinvyk were evaluated in a randomized controlled study of patients undergoing bunion or abdominal surgery.

The most common side effects were nausea, vomiting, dizziness, headache, and constipation. The drug carries a boxed warning of addiction, abuse, and misuse; respiratory depression; neonatal opioid withdrawal syndrome; and risks associated with concomitant use with benzodiazepines.

—Michael Potts

Reference:

FDA approves new opioid for intravenous use in hospitals, other controlled clinical settings. News release. August 7, 2020: US Food and Drug Administration; White Oak, Maryland. https://www.fda.gov/news-events/press-announcements/fda-approves-new-opioid-intravenous-use-hospitals-other-controlled-clinical-settings