Investigational agent improves interstitial cystitis pain

March 27, 2008

An investigational bladder instillation appears to improve daytime pain in patients with painful bladder syndrome/interstitial cystitis in a single dose, according to interim results of a phase II study.

An investigational bladder instillation appears to improve daytime pain in patients with painful bladder syndrome/interstitial cystitis in a single dose, according to interim results of a phase II study.

The multicenter, double-blind, crossover study compared URG101, a lidocaine and heparin solution, with placebo in 21 patients.

URG101 was significantly better than placebo in the primary efficacy measurement of improvement in daytime pain (p=.03). The drug also fared better than placebo in the secondary endpoints of improvement in daytime urgency (p=.03) and total symptom score (p=.03). In addition, patients reported improved symptom relief with the pharmaceutical treatment as measured by patients’ overall ratings of improvements of symptoms (p=.01), according to Urigen Pharmaceuticals, the drug’s manufacturer.

Additional analyses are ongoing. Results will be used to gauge whether additional patients will be enrolled in the study, which is designed for 50 subjects.