A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's Lesions

A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of LiRIS® 400 mg in Women With Ulcerative Interstitial Cystitis

The purpose of the study is to evaluate if LiRIS 400 mg is safe and tolerable when administered to women with Interstitial Cystitis with Hunner's lesions, and to evaluate any change in the bladder or in IC symptoms, following LiRIS administration.

Inclusion Criteria:

• Women age 18 and older
• Interstitial Cystitis with history of Hunner's lesions in the bladder
• Moderate to severe bladder discomfort
• Confirmation of Hunner's lesions in Bladder
• Able to report symptom (pain and voiding frequency) in a diary throughout the study

Exclusion Criteria:

• Pregnant women
• History or presence of bladder cancer
• History or presence of any condition that would make it difficult to evaluate bladder symptoms