What happened

Shares of Trevena (NASDAQ:TRVN) soared 31.5% on Monday after the biopharmaceutical company announced regulatory approval of its new pain-management treatment. 

So what

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.

A stethoscope surrounding the words pain management written on a piece of paper.

Trevena's stock soared on excitement for its new pain-relieving drug. Image source: Getty Images.

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."

Now what 

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.