The FDA will extend by three months the review time of GlaxoSmithKline and Adolor’s jointly-developed post-operative ileus treatment Entereg.
A decision on the drug had been expected on Sunday. The agency now plans to review the drug until May 10.
In January, an FDA panel voted in favor of approving Entereg but said that Adolor needed to come up with a better plan to ensure the drug is not taken by patients on a long-term basis. Regulators have expressed concern over safety data that shows Entereg may hurt patients’ cardiovascular system when taken over a long-term basis.
Adolor has submitted a new risk-management plan to the agency, which will account for the extra three months of review.
Post-operative ileus can affect patients after bowel surgery. Symptoms of the condition include constipation and other gastrointestinal dysfunction.
