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September 21, 2020 09:15pm
By Jill Murphy, Assistant Editor
The FDA has approved olicerdine (Olinvyk, Trevena) for use in patients with severe pain who require an IV opioid when alternative treatments prove to be inadequate.
Officials with the FDA have approved the opioid olicerdine (Olinvyk, Trevena) for intravenous (IV) use in the hospital setting.
Olicerdine is indicated for patients with severe pain who require an IV opioid when alternative treatments prove to be inadequate, according to the press release. It is only approved for short-term IV use in a controlled clinical setting and is not approved for at-home use.
In a controlled, open label trial, 1535 patients were treated with olicerdine. The patients were living with moderate to acute pain after undergoing a bunion or abdominal surgery. Safety and efficacy were established by comparing the opioid against a randomized placebo.
The recommended daily dose limit of olicerdine is 27 mg. Patients who received olicerdine reported a decrease in pain compared with the placebo. According to the press release, olicerdine has a safety profile that is similar to other opioids.
“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,” Deputy Director for Regulatory Programs in the FDA’s Center for Drug Evaluation and Research, Douglas Throckmorton, MD, said in the press release.
Common adverse reactions were nausea, vomiting, dizziness, headache, and constipation, which is similar to other opioids. According to the press release, olicerdine should not be administered in an unmonitored setting to patients with significant respiratory depression or severe bronchial asthma.
FDA Approves New Opioid for Intravenous Use in Hospitals, Other Controlled Clinical Settings (News Release), White Oak, MD, August 10, 2020, FDA, Accessed August 10, 2020