FDA Committee Votes to Combine Bladder Pain, Interstitial Cystitis Patients in Trials
An FDA advisory committee voted in favor of combining patients with bladder pain syndrome and interstitial cystitis in clinical trials.
The Bone, Reproductive and Urologic Drugs Advisory Committee voted 15 to 0 in favor of the recommendation in a Dec. 7 meeting.
Members broadly agreed that for both conditions the primary measure should be pain, but that it was too broad a category to stand on its own. They also agreed that other measures should include bladder function and quality of life measures such as sexual function.
The committee’s consensus was that because IC is a chronic condition the trial duration should be up to 24 months, as a 12-week trial would likely be inefficient in analyzing effectiveness of drugs for chronic conditions and would likely not be long enough to incorporate flare-ups in the condition.