GlaxoSmithKline, Adolor report mixed results from phase 3 alvimopan studies

By Elaine Rigoli

Tampa, Fla., Sept. 5 - GlaxoSmithKline and Adolor Corp. announced results from two identically designed phase 3 registration studies (012 and 013) of alvimopan (Entereg/Entrareg) for the treatment of opioid-induced bowel dysfunction in patients with chronic non-cancer pain.

The companies said Study 012 achieved statistical significance in its primary endpoint.

While Study 013 did not achieve statistical significance, the data showed supportive evidence in a key secondary endpoint of change in average weekly frequency of spontaneous bowel movement, according to a news release.

The pharmaceutical companies, London-based GlaxoSmithKline and Exton, Pa.-based Adolor, will investigate the data to understand the difference in Study 13 when compared with results from Study 12 and the earlier Study 11.

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