Adolor’s share price took a knocking on the Nasdaq Stock Exchange after it revealed that approval of its gastrointestinal drug, Entereg, (alvimopan), could face a delay after the US Food and Drug Administration asked the company to provide more information about its use in postoperative ileus.
The agency has specifically asked for information about a Phase III clinical trial conducted by the firm’s partner, GlaxoSmithKline. Preliminary data were released in December showed the drug failed to show a statistically significant improvement in recovery of gastrointestinal function in patients who had undergone bowel surgery, versus placebo.
“We will work closely with our partner GSK to provide this information to the FDA,” said Bruce Peacock, Adolor’s president and chief executive. “Our goal is to deliver the information in a time frame that would allow for an extension of three months to the Prescription Drug User Fee Act target action date of April 25, 2005.”