NeLM news service
Roche suspends dosing in trials of taspoglutide due to adverse reactions

Source: Reuters

Date published: 14/09/2010 17:19

Summary
by: Nicola Pocock

According to a Reuters report, Roche has stopped treatment with taspoglutide in Phase III clinical trials, due to a higher than expected rate of discontinuations due to gastrointestinal (GI) intolerability and serious hypersensitivity reactions.  In a statement Roche said that "these discontinuation rates compromise interpretation of the long term safety data from the T-emerge studies, therefore continuing treatment with the current taspoglutide formulation is not considered to be in the best interest of patients."

 

A spokesman said that "Roche is assessing approaches to identify the root cause of the serious hypersensitivity reactions and to optimise the taspoglutide formulation to improve GI tolerability.  Upon review of options available, Roche will communicate about the next steps of the overall taspoglutide program by year end."

 

According to the report, there were 23 cases of serious hypersensitivity reaction among 3,000 patients; all recovered without complications. The most frequently reported symptoms of hypersensitivity included skin reactions, nausea, and vomiting.  [No details of the GI effects were provided in the news report]

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