FDA Approves Oliceridine Injection, Opioid Agonist, for Clinical Settings

The FDA approved Olinvyk (oliceridine, Trevena Inc), an opioid agonist injection for the management of moderate to severe acute pain in adults, on August 7, 2020. The approval is for use of oliceridine for patients in whom the pain is severe enough to require an 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.

According to a press release issued by Trevena, "Olinvyk is an opioid agonist that is the first new chemical entity in this IV drug class in decades and offers a differentiated profile that addresses a significant unmet need in the acute pain management landscape. Olinvyk delivers IV opioid efficacy with a rapid 2-5 minute onset of action. In addition, Olinvyk requires no dosage adjustments in patients with renal impairment, a large patient population with significant medical complications."

FDA officials emphasized that the drug is approved only for clinical settings.

"Addressing the opioid crisis remains a top priority for the FDA. 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," said Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research. "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. 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."

A total of 1535 patients with moderate to severe acute pain were treated with oliceridine in controlled and open-label trials. Its safety and efficacy were established by comparing oliceridine to placebo in randomized, controlled studies of patients who had undergone bunion surgery or abdominal surgery. Patients who were treated with 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.

Olinvyk (the brand name of 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, Olinvyk has a maximum recommended daily dose limit of 27 mg.