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www.fdanews.com/articles/81391-urigen-s-ind-accepted-for-interstitial-cystitis-trial

URIGEN'S IND ACCEPTED FOR INTERSTITIAL CYSTITIS TRIAL

October 4, 2005

Urigen has announced that the FDA has accepted the company's investigational new drug application to initiate a Phase IIb clinical trial with its lead product, U101.

U101 is a proprietary intravesical formulation of FDA-approved components that has been demonstrated to provide near-immediate relief of symptoms associated with interstitial cystitis. The results of a successful open-label Phase IIa study were published in the Journal of Urology in February, and demonstrated that administration of U101 reduced the pain and urgency associated with interstitial cystitis in patients treated with the therapy.

The clinical trial is a prospective, randomized, double-blind, multicenter, placebo-controlled study of U101 in adult subjects with chronic pelvic pain and urgency of bladder origin. The objective of the study is to evaluate the safety and efficacy of the drug.