The US Food and Drug Administration has announced the approval of Olinvyk (oliceridine), a new opioid that can help manage moderate to severe acute pain in adults.
To test the drug, researchers enrolled 1,535 patients with moderate to severe acute pain in randomized, placebo-controlled, open-label trials. Administered to patients having undergone bunion or abdominal surgery, patients on the drug reported decreased pain when compared to those taking the placebo.
Approved for both inpatient and outpatient procedures, the drug is only available for short-term usage. Meanwhile, its maximum approved dose is 27mg, and its target market is high-risk patients, such as the elderly, those who are obese, or have renal problems.
Overall, the new drug has a similar safety profile to other opioids, and the FDA warns potential users and medical practitioners alike of its potential for abuse. Nevertheless, like other opioids, its most common side effects include nausea, vomiting, dizziness, headaches, and constipation. The FDA also notes that the drug should not be given to patients with significant respiratory depression and acute or severe bronchial asthma in an unmonitored setting without equipment for emergency resuscitation.
“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,” says 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.”
