The FDA has issued a letter stating it will only approve Entereg if the company provides 12-month safety data, including analysis of serious cardiovascular events from an ongoing safety study in opioid-induced bowel dysfunction. The FDA also requested a risk management plan as part of the submission.
The phase III safety study conducted by GSK is evaluating Entereg twice daily for the treatment of opioid-induced bowel dysfunction in patients with chronic non-cancer pain. The study is targeted for completion in the first quarter of 2007.
The new drug application for Entereg submitted to the FDA showed an increase in the reported incidence of serious cardiovascular adverse events in patients receiving alvimopan relative to placebo.
According to GlaxoSmithKline, reported events were in patients at high risk for cardiovascular disease and did not appear to be linked to duration of dosing. Furthermore, the company said events were consistent with epidemiological expectations for the subject population.
Entereg has already been delayed once before by the FDA after the drug produced mixed trial results earlier in the year. GlaxoSmithKline is developing the drug in partnership with Adolor.