GlaxoSmithKline (GSK) and Adolor (ADLR) Said Alvimopan Saftey Study Shows Serious Adverse Events

April 9, 2007 4:56 PM EDT

GlaxoSmithKline (NYSE: GSK) and Adolor Corporation (Nasdaq: ADLR) announced preliminary results from Phase 3 Safety study of Alvimopan. Current development program for OBD on-hold while findings from long-term safety study are evaluated.

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.

As a precautionary measure, GSK has taken the decision to stop Study 101684, an extension of Study 008 in a cancer pain population, which currently has 15 patients receiving treatment. Clinical investigators involved in this study have been informed. Adolor has also suspended enrollment in Study 228 in rotator cuff surgery patients.

"Patient well-being is always our primary concern. These unexpected findings are not yet fully understood and require further analyses to ascertain the significance of the data. We are working to gain a better understanding of these findings, which will help guide our future development," said Yvonne Greenstreet, Senior Vice President, Research and Development, GlaxoSmithKline.

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