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Once-Daily Formulation of Ciprofloxacin GR Shows Comparable Efficacy, Fewer Gastrointestinal Side Effects
"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 W. 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 commercialization partnership with a company which has a proven track record in the infectious disease market."
The randomized, 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 to 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 percent in the Ciprofloxacin GR arm compared with 89.6 percent with CIPRO. Overall gastrointestinal disorders, a complaint of some patients taking ciprofloxacin, were reported in 2.9 percent in patients treated with Ciprofloxacin GR and 5.1 percent in patients treated with CIPRO, with notably fewer patients complaining of nausea and diarrhea.
According to the American Foundation for Urological Disease, urinary tract infections result in as many as 10 million 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 U.S., with sales of $1.5 billion worldwide in 2002. Depomed has utilized its proprietary Gastric Retention (GR(TM)) technology to design once daily Ciprofloxacin GR for preferential absorption in the upper intestine.
Gastric Retention Technology
Depomed's Gastric Retention (GR) System is a patented, oral drug delivery technology designed specifically for drugs that are preferentially absorbed high in the gastrointestinal tract. Using normal physiological processes by which the stomach retains large objects for further digestion, the GR System swells following ingestion and is retained in the stomach for a number of hours, while it continuously releases the incorporated drug at a controlled rate to absorption sites in the upper intestinal tract. The controlled release of the drug at the preferred absorption site optimizes delivery of the drug during the "therapeutic window," potentially maximizing its therapeutic benefits and decreasing gastrointestinal side effects. GR-based products are designed to provide once daily administration, improving patient convenience, compliance and pharmacokinetic profiles.
Source: Depomed, Inc.