Business

Tue May 20 23:12:33 PDT 2008

(Adds details, share gain, previous dateline WASHINGTON)

NEW YORK, May 20 (Reuters) – GlaxoSmithKline Plc and Adolor Corp said on Tuesday U.S. regulators had approved their drug to help patients regain use of their bowels after bowel surgery, sending Adolor shares sharply higher.

The Food and Drug Administration cleared Entereg as a treatment for post-operative ileus, impairment that affects almost all patients undergoing surgery to remove part of the bowel.

The condition can prolong hospital stays and cause stomach bloating, pain, nausea and constipation.

The capsules had run into repeated regulatory delays, but an advisory panel to the FDA voted in January that the benefits of Entereg outweighed concerns about heart risks.

The FDA held up development of the drug last year after a large one-year study testing it for a different chronic bowel condition found an increased number of heart attacks, bone fractures and some cancers.

The drug was previously delayed when the FDA asked the companies to produce more clinical data.

Entereg will likely compete with Relistor, a drug from Wyeth and Progenics Pharmaceuticals Inc, that won U.S. approval last month to relieve constipation caused by opioid pain drugs, such as morphine.

Adolor shares rose 11.3 percent to $5.98 in after-hours electronic trading from their closing price of $5.37 on the Nasdaq.

(Reporting by Ransdell Pierson, Bill Berkrot and Susan Heavey in Washington; Editing by Andre Grenon)

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