FDA approves opioid drug

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The U.S. Food and Drug Administration (FDA) recently granted Trevena approval for an opioid agonist for use in adults with pain severe enough to require an intravenous opioid and for whom other treatments have been ineffective.

The drug, Olinvyk, is for the short-term intravenous management of moderate to severe acute pain. It is administered in hospitals or during inpatient and outpatient procedures.

“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 Dr. Douglas Throckmorton, 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.”

During the drug trials, 1,535 patients who had undergone bunion surgery or abdominal surgery were treated with Olinvyk. Compared to the placebo, patients given Olinvyk reported decreased pain.

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