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FDA Approves Trevena's Olinvyk Opioid For Use In Hospitals

trevenas aug10 lt

The U.S. Food and Drug Administration announced the approval of Trevena Inc.'s Olinvyk (oliceridine), a new opioid for intravenous use in hospitals or other controlled clinical settings.

Olinvyk is an opioid agonist to manage moderate to severe acute pain in adults, where the pain is severe enough to require an intravenous opioid and for whom alternative treatments are inadequate. It is indicated for short-term intravenous use, such as during inpatient and outpatient procedures, and not indicated for at-home use.

In controlled and open-label trials, a total of 1,535 patients with moderate to severe acute pain were treated with Olinvyk. In the trials, patients administered Olinvyk reported decreased pain compared to placebo at the approved doses.

Oliceridine was refused approval by the FDA in November 2018, and the company was asked to submit additional clinical data if it had to be approved.

According to the company, the addressable market opportunity for Oliceridine is large. It is estimated that over 45 million patients each year in U.S. hospitals receive drugs like IV morphine for acute pain.

The new opioid approval comes at a time the country is fighting opioid epidemic, which is deemed as the deadliest drug crisis the country has ever faced. It has been estimated that more than 130 people are dying from opioid-related drug overdoses every day in the United States. In 2018, opioids were involved in more than 46,000 drug overdose deaths.

In a statement, Douglas Throckmorton, deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research, said, "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.. ..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."

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