Today, the U.S. Food and Drug Administration approved Olinvyk (oliceridine), an opioid agonist for the management of moderate to severe acute pain in adults, where the pain is severe enough to require an intravenous opioid and for whom alternative treatments are inadequate.
Olinvyk is indicated for short-term intravenous 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. 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 M.D., 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 1,535 patients with moderate to severe acute pain were treated with Olinvyk in controlled and open-label trials. Its safety and efficacy were established by comparing Olinvyk to placebo in randomized, controlled studies of patients who had undergone bunion surgery or abdominal surgery. Patients administered Olinvyk reported decreased pain compared to placebo at the approved doses.
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