UTI success for Depomed

San Diego-based Depomed has released results from the Phase III clinical trial of its Ciprofloxacin GR, an extended release formulation of ciprofloxacin HCl, which is used to treat urinary tract infections.

The data confirmed Phase II results, demonstrating that Depomed's once-daily Ciprofloxacin GR eliminated the organisms responsible for urinary tract infections as effectively as twice-daily Cipro, but with fewer gastrointestinal side effects, specifically fewer incidences of nausea and diarrhoea.

'As we expected, our once-daily, extended release formulation of ciprofloxacin HCl has demonstrated positive pivotal clinical trial results which differentiate it from the existing twice-daily, immediate release Cipro product,' said John Fara, president, chief executive officer and chairman of Depomed. 'We expect our once-daily formulation will improve patient convenience and compliance and now, with these results, believe that patients will also benefit from fewer gastrointestinal complications. We look forward to submitting a New Drug Application to the FDA in the second quarter of 2004. We are also continuing to pursue a commercialisation partnership with a company which has a proven track record in the infectious disease market.'

The randomised, double-blind Phase III trial involved 580 evaluable patients with uncomplicated urinary tract infections (UTI). The trial was designed to evaluate the efficacy and safety of a three-day course of treatment with Depomed's once-daily Ciprofloxacin GR compared with a three-day course of treatment with twice-daily Cipro, an immediate release formulation. The preliminary analysis showed a microbial eradication rate of 93.5% in the Ciprofloxacin GR arm compared with 89.6% with Cipro. Overall gastrointestinal disorders, a complaint of some patients taking ciprofloxacin, were reported in 2.9% in patients treated with Ciprofloxacin GR and 5.1% in patients treated with Cipro, with notably fewer patients complaining of nausea and diarrhoea.