The opioid’s indication was based on several randomized controlled trials, where patients reported decreased pain.
The FDA has approved oliceridine (Olinvyk; Trevena Inc), an opioid agonist, for the management of pain that is severe enough to require an intravenous (IV) opioid and when alternative treatments were ineffective.
Oliceridine is indicated for short-term IV use in hospitals and other controlled clinical settings, including inpatient and outpatient procedures, and is not available for at-home use.
This approval was based on randomized, controlled, open-label trials (RCTs) that incorporated a total of 1535 patients with moderate-to-severe acute pain following bunion or abdominal surgery. Patients treated with oliceridine in the trials reported decreased pain compared with the placebo group within the approved doses.
The FDA also called attention to its continued commitment to addressing the opioid crisis and made mention of its robust review process for safety.
“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.
Similar to other opioids, the most common adverse effects of oliceridine are nausea, vomiting, dizziness, headache, and constipation. The FDA stressed that the drug should not be administered when a patient has significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; or known or suspected gastrointestinal obstruction. Oliceridine has a maximum recommended daily dose limit of 27 mg.
“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,” Throckmorton said.