The Food and Drug Administration (FDA) has approved Olinvyk (oliceridine; Trevena) for the management of adults with acute pain severe enough to require an intravenous (IV) opioid analgesic and for whom alternative treatments are inadequate.
Oliceridine is a full opioid agonist and is relatively selective for the mu-opioid receptor. It is indicated for short-term IV use in hospitals and other controlled clinical settings. Following an initial dose, the onset of analgesic effect is expected within 2 to 5 minutes.
The approval was based on data from 2 pivotal phase 3 studies that evaluated the efficacy of oliceridine in 790 adult patients with moderate to severe acute pain following orthopedic surgery-bunionectomy (APOLLO-1) and plastic surgery-abdominoplasty (APOLLO-2). Patients were randomized to receive oliceridine 0.1mg, 0.35mg, or 0.5mg, placebo or morphine using patient-controlled analgesia (PCA). Findings from both studies showed a statistically greater analgesic effect in the oliceridine 0.35mg and 0.5mg treatment groups vs placebo, as measured by the Summed Pain Intensity Differences over 48 hours (SPID-48) in APOLLO-1 and SPID-24 in APOLLO-2.
Additionally, an open-label, phase 3 study (ATHENA-1) found oliceridine to be safe and well tolerated in a medically complex patient population, including elderly and obese patients, and those with comorbid conditions (ie, diabetes, sleep apnea).
With regard to safety, the most common adverse reactions (≥10%) reported were nausea, vomiting, dizziness, headache, constipation, pruritus, and hypoxia. Olinvyk carries a Boxed Warning regarding the risks of addiction, abuse and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; and risks from concomitant use with benzodiazepines or other central nervous system depressants.
Because of these risks, even at recommended doses, Olinvyk should be reserved for use in patients for whom alternative treatment options have not been tolerated or have not provided adequate analgesia. Moreover, the cumulative total daily dose should not exceed 27mg, as doses >27mg/day may increase the risk for QTc interval prolongation.
“Addressing the opioid crisis remains a top priority for the FDA,” said Douglas Throckmorton MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “Of note, this particular medication is only indicated for use in a controlled clinical setting, meaning under medical supervision and not for use in a take-home prescription.”
Olinvyk is expected to be available in the fourth quarter of 2020 following final scheduling by the Drug Enforcement Administration (DEA). The product will be supplied as a preservative-free solution in 1mg/mL and 2mg/2mL single-dose vials and a 30mg/30mL single-patient-use vial for PCA use only.
For more information visit olinvyk.com.
1. FDA approves new opioid for intravenous use in hospitals, other controlled clinical settings. https://www.fda.gov/news-events/press-announcements/fda-approves-new-opioid-intravenous-use-hospitals-other-controlled-clinical-settings. Accessed August 10, 2020.
2. Trevena announces FDA approval of Olinvyk™ (oliceridine) injection. https://www.globenewswire.com/news-release/2020/08/10/2075464/0/en/Trevena-Announces-FDA-Approval-of-OLINVYK-oliceridine-injection.html. Accessed August 10, 2020.
3. Olinvyk [package insert]. Chesterbrook, PA: Trevena; 2020.