FDA approves opioid Olinvyk for patients with acute pain

pharmafile | August 10, 2020 | News story | Sales and Marketing opioid crisis, opioids 

The FDA has approved Olinvyk for the management of moderate to severe pain in adult patients when their pain is severe enough to require an intravenous opioid or if alternative treatments do not work.

The trial that led to its approval contained 1,535 patients with moderate to severe pain, with another study looking into the safety of the drug. The drug was found to be in line with the safety profile of other similar opioids with the most common side effects being nausea, vomiting, dizziness, headache and constipation. The treatment should also not be given to patients with significant respiratory depression like acute or severe bronchial asthma 

The drug, from Trevena Inc, was also proven to reduce pain compared to a placebo. Douglas Throckmorton M.D., the Deputy Director for Regulatory programs at the FDA’s Center for Drug Evaluation and Research, said on the approval: “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.

“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.”

Conor Kavanagh

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