GSK announces preliminary alvimopan trial results

GlaxoSmithKline (GSK) has announced the preliminary results of a phase III clinical study investigating the use of Entereg (alvimopan) in patients experiencing opioid-induced bowel dysfunction (OBD) when taking opioids for non-chronic cancer pain.

The results showed that patients administered with the compound exhibited similar gastrointestinal (GI) adverse events compared to those receiving alvimopan and placebo, with the rate of patients suffering serious adverse events was also similar.

However, the company reported a numerical imbalance in the proportion of neoplasm and cardiovascular serious adverse events in patients treated with alvimopan.

GSK is collaborating with Adolor on the global development and commercialisation of Entereg, the latter company’s lead candidate for the management of adverse GI effects related to the use of opioids.

Yvonne Greenstreet, senior vice-president of research and development at GSK, said: “These unexpected findings are not yet fully understood and require further analyses to ascertain the significance of the data.”

She added that the well-being of patients is the primary concern of the company, with the firm working to improve its understanding of the results of this clinical trial in order to aid its future development of the compound.

In May 2006, GSK and Adolor announced positive results of a phase IIb clinical study of alvimopan, with patients reporting a “significant” improvement in GI symptoms connected to their use of opioids.