GlaxoSmithKline and Adolor Corporation has announced data from Study and provided an update on the clinical development programme for alvimopan.

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 randomised 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 diarrhoea. 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.