The US Food and Drug Administration (FDA) has approved oliceridine (Olinvyk), an opioid agonist, for the management of moderate-to-severe acute pain in adults, where the pain is severe enough to require an intravenous (IV) opioid and for whom alternative treatments are inadequate.
Oliceridine is indicated for short-term IV use in hospitals or other controlled clinical settings, such as during inpatient and outpatient procedures. It is not indicated for at-home use.
“Addressing the opioid crisis remains a top priority for the FDA,” said Douglas Throckmorton, MD, FDA Center for Drug Evaluation and Research, Rockville, Maryland. “We will continue to do everything we can to reduce the number of Americans who are addicted to opioids and cut the rate of new addiction through a number of cross-agency initiatives.”
“Importantly, the FDA will only approve new drug applications, including those for opioid medications, following a rigorous review to evaluate the risks and benefits and ultimate determination that the data support safety and effectiveness,” he continued. “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.”
The safety and efficacy of oliceridine were demonstrated in randomised, controlled studies that compared the drug with placebo in 1,535 patients with moderate-to-severe acute pain who had undergone bunion surgery or abdominal surgery.
Patients administered oliceridine reported decreased pain compared with placebo at the approved doses.
The safety profile of oliceridine is similar to other opioids. As with other opioids, the most common side effects of oliceridine are nausea, vomiting, dizziness, headache, and constipation.
Oliceridine should not be given to patients with significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; known or suspected gastrointestinal obstruction; or known hypersensitivity to the drug.
Prolonged use of opioid analgesics during pregnancy can result in neonatal opioid withdrawal syndrome.
Oliceridine carries a boxed warning about 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.
Unlike other opioids for IV administration, oliceridine has a maximum recommended daily dose limit of 27 mg.