Depomed provide encouraging results

The interim results from US biotech company Depomed's Phase III trial of Ciprofloxacin GR for the treatment of uncomplicated urinary tract infections (UTI) show that the drug can be used successfully against the disease.

Although the trial is still blinded, clinical analysis indicated that patients treated with either once-daily Ciprofloxacin GR or twice-daily Cipro, Bayer's twice daily, immediate release formulation, exhibited comparable eradication of the organisms responsible for causing UTIs.

The Phase III trial is two-thirds enrolled and Depomed expects to complete it in Q1 2004.

In Phase I and Phase II trials, Ciprofloxacin GR has been shown to eliminate UTIs as effectively as Cipro but with fewer side effects. Antibiotics such as Cipro can cause nausea and diarrhoea when they kill beneficial bacteria that live in the lower intestine. Ciprofloxacin GR is designed to be preferentially absorbed in the upper intestine, utilising Depomed's gastric retention drug delivery system, which allows once-daily, oral, controlled release of the drug.

'The current data reinforce the results of our previous Phase II trial in which Ciprofloxacin GR was shown to be as effective as Cipro in the treatment of UTIs, but with the added convenience of once-a-day dosing,' said ceo John Fara. 'Patient enrollment for this trial is currently on schedule, and we look forward to continuing our momentum with both Ciprofloxacin GR and Metformin GR, which will complete the clinical portion of its second pivotal Phase III trial for the treatment of Type II diabetes this October.'

The analysis of the Ciprofloxacin GR Phase III trial evaluated the laboratory results of the treated patients, some of whom received 500 mg of once daily Ciprofloxacin GR and the balance of whom received 250 mg of Cipro twice daily. At both one week and five weeks following treatment, patients in both groups exhibited comparable evidence of eradication of causative organisms of UTI. Additional data, including data relating to any adverse events, will be available following the completion of the Phase III trial.

Urinary Tract Infections

According to the American Foundation for Urological Disease, urinary tract infections (UTIs) result in as many as 10m visits to physicians each year. UTIs are bacterial infections frequently caused by E. coli and are typically treated with antibiotics. Bayer's Cipro is the leading oral antibiotic in the US, with sales of $1.5bn worldwide in 2002. Depomed has utilised its proprietary Gastric Retention (GR) technology to design once daily Ciprofloxacin GR for preferential absorption in the upper intestine.