FDA approves oliceridine for acute severe pain for IV use in hospitals

Oliceridine is indicated where the pain is severe enough to require an intravenous opioid and for whom alternative treatments are inadequate.

The Food and Drug Administration has granted approval of Olinvyk to Trevena, Inc.

One of the highest priorities of the Food and Drug Administration is advancing efforts to address the crisis of misuse and abuse of opioid drugs harming families.

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 Food and Drug Administration. 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 Food and Drug Administration 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.

The safety profile of Olinvyk is similar to other opioids. As with other opioids, the most common side effects of Olinvyk are nausea, vomiting, dizziness, headache and constipation. Olinvyk should not be given to patients with significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; known or suspected gastrointestinal obstruction; or known hypersensitivity to the drug. Prolonged use of opioid analgesics during pregnancy can result in neonatal opioid withdrawal syndrome.

Olinvyk carries a boxed warning about addiction, abuse and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; and risks from concomitant use with benzodiazepines or other central nervous system depressants. Unlike other opioids for intravenous administration, Olinvyk has a maximum recommended daily dose limit of 27 milligrams.

• SOURCE U.S. Food and Drug Administration
• Related link

http://www.fda.gov

Additional Resources:

• FDA: Opioid Medications