Trevena said the U.S. Food and Drug Administration (FDA) approved its new opioid agonist, called Olinvyk, for the management of acute pain in adults severe enough to require an intravenous opioid pain reliever -- and for whom other treatments are insufficient.
In trials with a total of more than 1,500 participants, Olinvyk demonstrated rapid pain-relieving effects in as little as 2-5 minutes. Olinvyk was also shown to be safe and well-tolerated in a variety of people, including those with medical complications.
"Complex patients present unique challenges in the management of their postoperative acute pain, due to the presence of medical comorbidities that can complicate dosing," Stanford University professor Gregory Hammer said in a press release. "Olinvyk represents a new alternative for clinicians, due to its rapid onset of action, effective pain relief, and unique profile."
Trevena intends to make Olinvyk commercially available in the fourth quarter after the U.S. Drug Enforcement Administration (DEA) issues its controlled substance schedule in approximately 90 days. Pain management is a massive market, with roughly 45 million hospital patients in the U.S. alone receiving IV opioid treatments each year.