VANCOUVER, British Columbia and SAN FRANCISCO, Oct. 3 /PRNewswire/ -- Urigen Inc. today announced that the United States FDA has accepted the company's investigational new drug (IND) 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 2005 and demonstrated that administration of U101 reduced the pain and urgency associated with interstitial cystitis in patients treated with the therapy. (J. Urology 65: 45-48, 2005.)

Urigen's Phase IIb clinical trial is a prospective, randomized, double- blind, placebo-controlled Phase II 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 U101 in a multi-center trial.

"We are very pleased with the interaction with the FDA," stated William J. Garner, MD, President & CEO of Urigen. "The agency's input was valuable and may potentially streamline the development of this important product."

About Interstitial Cystitis

Interstitial cystitis (IC) is chronic condition of the bladder resulting in pain, urgency, frequency and overactive bladder. Approximately 750,000 women present to urologists with these symptoms in the United States each year. In addition, a significantly larger population presents to OB/GYN physicians with these symptoms. Published reports estimate that IC affects up to 0.5% of the female population in North America and a smaller number of men. In the most severe cases, IC is highly debilitating and may require surgical and or narcotic intervention.

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