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news.GlaxoSmithKline and Adolor Corporation have reported that results from a phase III safety study of the constipation drug Entereg, suggest the drug is linked to heart problems and a variety of other risk factors.
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GSK and Adolor have suspended two studies investigating Entereg, until further analysis of the data has been completed. The FDA had requested an additional safety study for Entereg in a November approval letter to the companies.
While the proportion of patients experiencing serious adverse events in the study was similar between those treated with Entereg and placebo, the data suggest an increased risk in the number of cardiovascular and neoplasm cases among Entereg-treated patients.
Results from the completed study showed an increase in myocardial infarctions and all cardiovascular events reported by patients treated with Entereg compared to placebo. The cardiovascular events reported occurred in patients with established or at high risk for heart disease.
An increase in the incidence of fractures was also observed in patients receiving Entereg and the study also showed an increase in the risk of developing skin cancers.
Adolor said despite the unexpected results that it still plans to submit a complete response in the second quarter of 2007 to the FDA approvable letter.