What new non-opiate (non-opioid) analgesic drug was FDA (Food and Drug Administration) approved for moderate to severe pain?

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Last updated: March 7, 2025View editorial policy

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From the Research

Oliceridine (brand name Olinvyk) is the most recent non-opioid analgesic approved by the FDA for moderate to severe acute pain in adults. Approved in August 2020, oliceridine is administered intravenously in hospital or controlled clinical settings. The typical dosing is 1.5 mg initially, with subsequent doses of 0.35 to 0.5 mg as needed, with a maximum daily dose of 27 mg. While technically classified as an opioid, oliceridine represents a novel approach as a G-protein biased mu-opioid receptor agonist that provides pain relief with potentially fewer side effects than traditional opioids. It selectively activates the pain-relieving G-protein pathway while minimizing activation of the beta-arrestin pathway associated with respiratory depression and gastrointestinal side effects. This medication is not intended for outpatient use and should be administered under medical supervision for acute pain management, typically for no more than 24-48 hours.

Key Points

  • Oliceridine is a novel non-opioid analgesic approved for moderate to severe acute pain in adults 1
  • It is administered intravenously in hospital or controlled clinical settings
  • Typical dosing is 1.5 mg initially, with subsequent doses of 0.35 to 0.5 mg as needed
  • Maximum daily dose is 27 mg
  • Oliceridine is a G-protein biased mu-opioid receptor agonist with potentially fewer side effects than traditional opioids

Mechanism of Action

Oliceridine works by selectively activating the pain-relieving G-protein pathway while minimizing activation of the beta-arrestin pathway associated with respiratory depression and gastrointestinal side effects 1. This mechanism of action provides pain relief with potentially fewer side effects than traditional opioids.

Administration and Dosage

Oliceridine is administered intravenously in hospital or controlled clinical settings. The typical dosing is 1.5 mg initially, with subsequent doses of 0.35 to 0.5 mg as needed, with a maximum daily dose of 27 mg 1. This medication is not intended for outpatient use and should be administered under medical supervision for acute pain management, typically for no more than 24-48 hours.

References

Research

Three newly approved analgesics: an update.

Anesthesia progress, 2013

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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