Novel Opioid Olinvyk Approved for Use in Clinical Settings

August 10, 2020 – The U.S. FDA has approved OlinvykTM (oliceridine) injection, manufactured by Trevena, for use in adults for whom alternative treatments are inadequate to manage acute pain severe enough to require an intravenous opioid analgesic.

Olinvyk is a novel opioid indicated for short-term intravenous (IV) use under in hospitals or other controlled clinical settings. Each year, an estimated 45 million hospital patients receive an IV opioid to treat acute pain. In many instances, these patients have complex medical concerns that can present challenges when opioids are needed to provide adequate pain relief.

In clinical studies, Olinvyk demonstrated rapid analgesic efficacy (onset of action within 2-5 minutes) that was statistically significant compared to placebo in patients who had undergone hard- or soft-tissue surgery. In addition, the drug was found to be safe and well-tolerated in a medically complex patient population, including the elderly, obese, and patients who have comorbid conditions such as diabetes and sleep apnea. It also requires no dosage adjustment in patients who have renal impairment.

Recommended dosing is an initial dose of 1.5mg administered intravenously by a healthcare professional. Olinvyk can be made available for 0.35mg or 0.5mg intravenous patient-controlled analgesia with a six-minute lockout. Supplemental doses of 0.75mg can be administered by a healthcare professional one hour after the initial dose, and hourly thereafter, if needed. Single doses of Olynvyk should not exceed 3mg. The total cumulative daily dose should not exceed 27mg, as total daily doses greater than 27mg may increase the risk for QTc interval prolongation, a potentially fatal heart rhythm problem.

A black box warning cautions that, like other opioids, Olinvyk carries a risk of addiction, abuse and misuse; life-threatening respiratory depression; and neonatal opioid withdrawal syndrome. There is also a black box warning for risk of profound sedation, respiratory depression, coma, and death if Olinvyk is used concomitantly with benzodiazepines or other central nervous system depressants.

Olinvyk is expected to launch during the fourth quarter of 2020, after it has been scheduled as a controlled substance by the U.S. Drug Enforcement Administration (DEA). Pricing information is not yet available.