Urigen Pharmaceuticals, Inc. (OTCBB:URGP), a specialty pharmaceutical company focused on the development of treatments for urological disorders and pain, announced today that it has filed a request for an FDA meeting to advance the URG101 clinical program and mutually agreed with Oceana Therapeutics, Inc. to terminate their Consulting Agreement effective immediately.
“Urigen's request to meet with the US Food and Drug Administration was filed yesterday. We look forward to working with the FDA as we move our URG101 program forward for Painful Bladder Syndrome/Interstitial Cystitis”
"Urigen's request to meet with the US Food and Drug Administration was filed yesterday. We look forward to working with the FDA as we move our URG101 program forward for Painful Bladder Syndrome/Interstitial Cystitis," said William J. Garner, MD, CEO.
"Ending our contractual obligation to Oceana enables us to pursue several additional commercial opportunities in the US and the EU more aggressively," stated, Edward R. Teitel, MD, JD, Chairman of Urigen.
Prof. Lowell Parsons, MD said, "After 30 years, in my opinion, from my clinical experience with URG101, it is the most significant advance in treating interstitial cystitis/painful bladder syndrome that has yet been developed and will greatly improve the quality of patients' lives."
URG101 is a patent-protected, regional therapy for Painful Bladder Syndrome/Interstitial Cystitis which afflicts millions of women and men. Urigen has previously announced positive results from a Phase 2 study of URG101. The study was a multi-center, double-blind, placebo-controlled, crossover trial. Findings from the study included: Primary Endpoint - Improvement in Average Daytime Pain>
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