( LONDON & EXTON Pa.--(BUSINESS WIRE...)GSK and Adolor Announce Preliminary Results from Phase 3 Safety,Study of Alvimopan (Entereg/Entrareg),Health

Study 014, a Phase 3, double blind, placebo-controlled (12 month) study, was designed to evaluate the long-term safety and tolerability of alvimopan 0.5 mg twice daily in patients taking opioids for chronic non-cancer pain and experiencing opioid-induced bowel dysfunction (OBD). A total of 805 patients were enrolled into the study and randomized 2:1; a total of 538 patients received alvimopan and 267 received placebo.

Consistent with findings from previous studies the most common adverse events observed in Study 014 were those affecting the gastrointestinal (GI) tract, including abdominal pain and diarrhea. The incidence of GI adverse events observed was similar between patients treated with alvimopan (40%) and placebo (35%).

While the proportion of patients experiencing serious adverse events was similar between those treated with alvimopan (13%) and placebo (11%), a numerical imbalance was observed in the number of cardiovascular (CV) and neoplasm cases categorized as serious adverse events among alvimopan-treated patients.

Preliminary findings from Study 014 are outlined below, together with information regarding actions taken by GSK and Adolor regarding the two ongoing alvimopan studies.

Cardiovascular Adverse Events

Results from a six-month interim analysis of Study 014, previously announced in November 2006, showed an increase which was not statistically significant in the reported incidence of serious CV adverse events in patients receiving alvimopan relative to placebo. Results from completed Study 014 showed an increase in myocardial infarctions and all CV SAEs reported by patients treated with alvimopan c
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