Interstitial Cystitis Advice

Story originally posted on October 4, 2005

Newcomer pharmaceutical company Urigen has announced that the FDA has officially accepted an application by the company to have their new investigational drug application put through to clinical trial phase Ilb. The product in question? U101, a new Interstitial Cystitis/pelvic pain drug.

This medication is intravesical, meaning it is instilled directly into the bladder, and is comprised of a formulation of FDA approved components that have are known to help Interstitial Cystitis (IC). So far trials have gone very well, as the company noted in the February 2005 edition of the Journal of Urology (J. Urology 65: 45-48, 2005.). It is being reported that that U101 offers near immediate symptom relief, and in the Journal of Urology they noted that it helped to reduce the pain and urgency associated with IC.

This phase of the trial study is a randomized, double blind, placebo-controlled Phase II study of U101in adults with urgency and chronic pelvic pain of bladder origin (including IC). The aim is to determine the safety of U101 in a multi-centre trial.

Thus far further information is not publicly available, so it is difficult to speculate if this new drug would be more affective than other intravesical drugs such as DMSO and Heparin, which are commonly in practice for the treatment of IC. Should this drug make to the market (and your urologist’s office!), we can only hope that it does in fact provide near immediate symptom relief, as this would be something of an IC miracle.

Information resources:

Urigen Opens IND for Phase IIb Clinical Trial with Novel Treatment for Interstitial Cystitis