Trevena Inc. (NASDAQ: TRVN) saw its shares make a handy gain to start out Wednesday after the firm announced that the U.S. Food and Drug Administration (FDA) accepted its most recent New Drug Application (NDA). Specifically, this NDA deals with Olinvo (oliceridine) injection, which helps manage moderate-to-severe acute pain in hospital or similar settings.
Previously, Olinvo had been granted Breakthrough Therapy designation by the FDA, allowing for an expedited review process.
Looking ahead, the company expects a Priority Drug User Fee Act (PDUFA) date in the fourth quarter of 2018.
Olinvo was specifically designed to deliver the pain relief of a conventional IV opioid, with fewer associated adverse effects. In its Phase 2 and Phase 3 clinical trials, Olinvo provided rapid and powerful analgesic efficacy while demonstrating a wider therapeutic window compared to morphine. Ultimately this suggests that Olinvo may be highly effective and well-tolerated for patients in need of strong analgesia.
Maxine Gowen, Ph.D., CEO, 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.
Excluding Wednesday’s move, Trevena had underperformed the broad markets and was down about 69% over the past 52 weeks. Over the past six months, the stock was only down about 22%.
Shares of Trevena traded up 7.8% at $1.94 Wednesday morning, with a consensus analyst price target of $7.79 and a 52-week range of $1.35 to $8.00.