FDA lifts clinical hold on Adolor bowel drug

The drug is being developed in partnership with GlaxoSmithKline PLC. It was approved in May to treat postoperative ileus (POI), or constipation following abdominal surgery, after regulators said its benefits outweighed the potential increased heart attack risk.

"After a productive meeting and dialogue with FDA, we are very pleased to see the clinical hold lifted," said Michael R. Dougherty, president and chief executive. "There remains a large, unmet need for treatment options for the many patients suffering from this debilitating condition."

Adolor said British drugmaker Glaxo is evaluating all options related to Entereg, including whether to proceed with its involvement in the opioid-related constipation program. The companies' partnership agreement, which dates back to April 2002, allows Glaxo to end its involvement with Entereg as a treatment for opioid-induced constipation but maintain its rights to the drug as a treatment for POI.

Adolor said that if Glaxo discontinues their partnership, the company will itself submit an additional study protocol to the FDA. The agency had said in the past that the company wasn't doing enough to manage the risk of potentially dangerous side effects.