The Drug Enforcement Administration (DEA) has designated Olinvyk (oliceridine; Trevena) as a Schedule II controlled substance, similar to other intravenous (IV) opioids that are administered in a hospital setting.
The Food and Drug Administration (FDA) approved Olinvyk in August 2020 for the management of adults with acute pain severe enough to require an IV opioid analgesic and for whom alternative treatments are inadequate. It is a full opioid agonist and is relatively selective for the mu-opioid receptor. 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 Olinvyk in 790 adult patients with moderate to severe acute pain following orthopedic surgery-bunionectomy (APOLLO-1) and plastic surgery-abdominoplasty (APOLLO-2). Findings from both studies showed a statistically greater analgesic effect with Olinvyk vs placebo.
Additionally, an open-label, phase 3 study (ATHENA-1) found Olinvyk 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).
As for safety, the most common adverse reactions associated with Olinvyk include nausea, vomiting, dizziness, headache, constipation, pruritus, and hypoxia. Olinvyk may also increase the risk of QTc interval prolongation if the cumulative total daily dose exceeds 27mg (not recommended).
Additionally, 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.
“We made the decision earlier this year to begin manufacturing commercial product, so that physicians could have access to Olinvyk for their hospitalized acute pain patients as soon as possible upon approval and DEA scheduling,” said Carrie Bourdow, President and CEO of Trevena, Inc. “We look forward to making Olinvyk available for ordering in November.”
Olinvyk 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 trevena.com.
- Trevena, Inc. announces DEA scheduling of Olinvyk™ (oliceridine) injection. [press release]. Chesterbrook, PA: Trevena, Inc; October 30, 2020.
- Olinyvk [package insert]. Chesterbrook, PA; Trevena, Inc; 2020.