Solvay Pharmaceuticals suspends US cilansetron registration, continues in UK

Solvay Pharmaceuticals has announced that it has suspended regulatory activities for cilansetron with the US Food and Drug Administration (FDA).

The Brussels company said that the amount of clinical work requested by the FDA was not justified when it considered the potential market for the 5-HT3 receptor antagonist used to decrease gastrointestinal motility, secretion, and sensation.

The company said it prefers to give priority to the development of other compounds in its research and development pipeline.

However, the company did say that discussions on cilansetron with the UK Medicines and Healthcare Products Regulatory Agency would continue.

The UK is a reference member state for drug registration in the EU and Solvay said it expects to announce its decision for Europe during 2006.

Trials involving cilansetron on its efficacy and safety have included more than 4,000 patients worldwide, both men and women, with diarrhea predominance (D-IBS). Both men and women recorded symptom improvements and improved quality of life, said Solvay.

IBS affects more than 11 per cent of the EU population, with total annual direct costs estimates of some ?45 million in the UK alone.

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