What happened
Shares of Trevena (NASDAQ: TRVN) went up 31.5% on Monday after the biopharmaceutical company announced regulatory approval of its new treatment for pain management.
So what
Trevena said the US Food and Drug Administration (FDA) has approved its new opioid agonist, named Olinvyk, for the management of acute pain in adults who are severe enough to require an injectable opioid painkiller – and for whom other treatments are not enough.
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 managing 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.”
Well what
Trevena intends to make Olinvyk commercially available in the fourth quarter after the U.S. Drug Enforcement Administration (DEA) issued its controlled substance schedule in about 90 days. Pain management is a massive market, with approximately 45 million hospital patients in the U.S. receiving only IV opioid treatments each year.