Investigational New Drug Application for RTGel™ in Combination with BOTOX® for the Treatment of Overactive Bladder Submitted to FDA by Allergan
“Our licensing agreement with
About Overactive Bladder and RTGelTM
Overactive Bladder (OAB) is a common, often disabling condition associated with considerable negative impact on quality of life. OAB results in an uncontrolled urge to urinate, frequent urination and, in many patients, uncontrollable leakage of urine. Standard first line treatment for OAB is anticholinergic pills, however, the majority of the patients stop taking the pills within one year due to an inadequate response to, or intolerance of, the medication. BOTOX® injection into the bladder is approved as second line therapy for OAB and is considered an effective therapeutic option.
Over 30 million people in
RTGel™ has thermo-sensitive properties that enable it to convert from a liquid state when cold, into a gel once it reaches body temperature. This allows increased residence time of drugs when mixed with the gel and instilled in the bladder.
Forward Looking Statements
This press release contains forward-looking statements, including with respect to the development potential of RTGel/BOTOX®, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the timing and success of clinical trials; the ability to obtain and maintain regulatory approval; the labeling for any approved product; the scope, progress and expansion of developing and commercializing a product candidate, the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; and the maintenance of any applicable collaborations. In light of these risks, uncertainties and assumptions, the events and circumstances discussed in such forward-looking may not occur, and UroGen Pharma’s actual results could differ materially and adversely from those anticipated or implied thereby.
UroGen Pharma Ltd. Gary TitusChief Financial Officer firstname.lastname@example.org 646-768-9531 Or Burns McClellan, Inc. Steve Klasssklass@burnsmc.com 212-213-0006