Chesterbrook-based Trevena saw its stock surge by 50 percent after the FDA approved its new pain medicine on Monday, writes John George for the Philadelphia Business Journal.
The company’s drug, Olinvyk, has been approved for adults for the management of acute pain that requires an intravenous opioid analgesic.
Olinvyk was designed to produce a rapid onset of action within a few minutes and has fewer side effects than traditional opioids. It is administered intravenously in hospital and healthcare settings.
The drug is expected to be commercially available in around 90 days, after the U.S. Drug Enforcement Administration issues its controlled substance schedule.
“We will work quickly to bring this novel IV analgesic to patients and healthcare providers in need of alternative treatment options,” said Trevena CEO Carrie L. Bourdow.
In late 2018, the FDA rejected the initial new drug application for the Trevena opioid. The agency requested additional clinical data regarding QT prolongation, as well as additional nonclinical data and validation reports.
The company resubmitted its new drug application for Olinvyk with requested additions in February.
Read more about Trevena in the Philadelphia Business Journal here.
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