Shares of Canada's Labopharm tanked this morning after the developer said that its twice-daily pain med failed to hit its primary endpoint in a late-stage trial, setting up a likely rejection at the FDA.
Researchers said that a twice-daily formulation of tramadol and acetaminophen did not demonstrate a statistically significant affect when judging pain-intensity differences by one standard. But the company noted that there were other methods that could be used to evaluate the drug that did demonstrate efficacy, which could help make their case for the drug in Europe and other markets. Investors didn't like what they had heard, though, sending Labosharm's stock down 25 percent.
The bad news came in reference to the FDA.
"Labopharm believes that it is likely that the results of this trial are insufficient to support the acceptance of a New Drug Application (NDA) by the Food and Drug Administration in the United States," the developer warned. "The company intends to discuss the matter with the FDA's Division of Anesthesia, Analgesia & Rheumatology Products to determine the path forward."
Labopharm also noted that the trial data would have no impact on its plans to market its once-daily tramadol product in the United States.
- read the Labopharm release