Trevena shares were on fire in after hours trading on Tuesday after the biotech company announced that the Food and Drug Administration has accepted for review a new drug application (NDA) of the company’s opioid-replacement painkiller, Olinvo.
Shares were up as much as 25% after Wall Street got wind of the enws. The FDA is expected to make a decision in the fourth quarter of 2018 according to the company.
Trevena has said that Olinvo, an investigational product to manage moderate to sever acute pain, has shown it delivers the pain relief of conventional opioid like morphine however with fewer adverse effects.
Olinvo is the first G protein biased ligand of the mu receptor designed to provide IV opioid pain relief with fewer associated adverse effects. In Phase 2 and Phase 3 clinical trials, OLINVO provided rapid and powerful analgesic efficacy all while demonstrating a wider therapeutic window compared to morphine.
CEO Maxine Gowen, Ph.D., commented, “The NDA file acceptance represents another major step in our progress towards delivering OLINVO to patients and healthcare providers in need of new options for managing moderate to severe acute pain in the hospital setting. We look forward to working with the FDA as they evaluate the OLINVO application.”
Disclaimer: We have no position in Trevena Inc. (NASDAQ: TRVN) and have not been compensated for this article.