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Depomed submits Proquin XR

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Depomed files its once-daily, extended-release ciprofloxacin formulation Proquin XR for treatment of uncomplicated urinary tract infections, the firm announces July 20. The NDA is based on a single Phase III trial in 1,037 patients comparing a three-day course of Proquin XR to three days of twice-daily immediate release ciprofloxacin (Bayer's Cipro). The study showed an eradication rate of 93.4% for Proquin XR compared to 89.6% for Cipro. Depomed will highlight fewer gastrointestinal side effects; in the clinical trial Proquin patients had "five-fold fewer complaints of nausea and seven-fold fewer cases of diarrhea." Depomed's Gastric Retention technology provides for "preferential absorption in the upper intestine." The company is "in discussions with potential marketing partners" and "evaluating the opportunity to co-promote the product in certain markets"...

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