Opioid Resource Center

Opioid Resource Center

Disclosures: Healio Primary Care was unable to confirm Hammer’s relevant financial disclosures at the time of publication.
August 10, 2020
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FDA OKs novel IV treatment Olinvyk for acute pain

Disclosures: Healio Primary Care was unable to confirm Hammer’s relevant financial disclosures at the time of publication.
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The FDA has approved Olinvyk — the first new IV chemical opioid agonist in decades — for adults with acute pain, the drug’s manufacturer announced.

Olinvyk (oliceridine, Trevena) is intended for patients with pain “severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate,” the manufacturer said.

Approved stamp
Olinvyk, a recently approved drug that is intended for patients with pain “severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate,” should be available for use within 90 days, according to its manufacturer.  Photo Source: Adobe Stock

Trevena said the safety and efficacy of oliceridine were established in trials totaling 1,535 patients who were older, obese, diabetic and/or had sleep apnea and underwent orthopedic surgery-bunionectomy or plastic surgery-abdominoplasty. The drug requires no dosage adjustments in patients with renal impairment and provides pain relief within 2 to 5 minutes of its administration.

“Complex patients present unique challenges in the management of their postoperative acute pain, due to the presence of medical comorbidities that can complicate dosing,” said Gregory Hammer, MD, professor of anesthesiology, perioperative and pain medicine at Stanford University in a Trevena press release. “Olinvyk represents a new alternative for clinicians, due to its rapid onset of action, effective pain relief and unique profile.”

The FDA said in a separate release that oliceridine will only be available in controlled clinical settings and is not designed for at-home use.

Adverse events associated with oliceridine include constipation, dizziness, headache, hypoxia, nausea, pruritus and vomiting, Trevena said. The company added that oliceridine will be available after the United States Drug Enforcement Administration assigns the drug to its schedule of controlled substances, which is expected within about 90 days.

FDA Press Release