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UPDATE 2-Benefits trump risks to Adolor bowel drug-FDA panel
Wed Jan 23, 2008 5:37pm EST By Kim Dixon
(Adds FDA action data, risk management plan, rivals, comments)
SILVER SPRING, Md., Jan 23 (Reuters) - The benefits of Adolor Corp (ADLR.O: Quote, Profile, Research) and GlaxoSmithKline's (GSK.L: Quote, Profile, Research)(GSK.N: Quote, Profile, Research) experimental bowel drug Entereg outweigh its risks, U.S. regulatory experts said on Wednesday.
The advisory panel to the U.S. Food and Drug Administration voted 9-to-6 that long-term risks to the heart are outweighed by the drug's effectiveness, including cutting recovery time after bowel surgery and time in the hospital by about one day.
The FDA typically takes the advice of expert panels.
The companies are seeking approval for post-operative ileus (POI), a gastrointestinal disorder, that is common after bowel resection surgery, and marked by stomach bloating and pain, nausea, and constipation. No drugs are approved to treat POI.
Adolor and Glaxo are pushing ahead with development of Entereg for use against POI, despite having to suspend its tests for another bowel disorder after a higher number of heart attacks, bone fractures and abnormal tissue growth was seen in patients taking the drug.
The companies estimate it could be used in about 400,000 patients recovering from surgery in the hospital, annually.
"I think for the patient's sake I would agree that the benefits marginally overcome the negative," panel member Dr. Robert Levine, a professor in gastroenterology at the State University of New York in Syracuse said.
Entereg blocks the negative effects of the powerful opioid painkillers, such as morphine, on bowel motility. The FDA is expected to take action on the drug by February 10.
Wyeth (WYE.N: Quote, Profile, Research) and biotech Progenics Pharmaceuticals (PGNX.O: Quote, Profile, Research) are working on a similar drug, although U.S. regulators earlier this month delayed that review because of the drug's potential for disrupting the heart's electrical system.
HEART RISKS "A CONCERN"
Earlier in the meeting, a majority of panel members said they were "concerned" about the long-term cardiovascular risks with Entereg.
The FDA last year held up development of the drug after a large one-year study testing the drug for a separate chronic bowel condition found an increased number of patients on the drug had heart attacks, bone fractures and some cancers.
A GlaxoSmithKline official described those findings as an anomaly, blaming sicker patients and arguing that a small number of events made the results difficult to interpret. Still, Glaxo proposed an additional study to probe the safety risk signal.
The evidence suggests "this is not really just a chance finding," Michael Proschan, a panel member and statistician based in Maryland, who voted against approval, said.
In the companies' studies for the surgery use, the FDA found a heart attack rate similar to that of a placebo, but the FDA staffers said no conclusion about long-term risks such as heart attack could be drawn because of limited patient follow-up.
Most patients were tracked for a maximum of two weeks. In the earlier study for a different bowel disorder, when a higher number of heart attacks were seen, patients were followed for up to a year.
Panel members were unimpressed by a proposed "risk map," a plan that the FDA asked the company to submit to mitigate potential risks to the drug. It included limiting distribution and educating doctors.
"I think the risk map done by the company was done very haphazardly," Dr. Alan Buchman, associate professor in gastroenterology at Northwestern University, said.
Buchman and others worried that once the drug reached the market, surgeons would use it in non-bowel surgeries for which it was not tested. (Reporting by Kim Dixon; Editing by Jeffrey Benkoe and Carol Bishopric) |
