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# Interstitial Cystitis/Bladder Pain Syndrome Guidance
- URL: https://www.fdaweb.com/interstitial-cystitis-bladder-pain-syndrome-guidance/
- Published: 2023-06-02T12:00:00.000Z
- Updated: 2026-09-14T18:35:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154605

FDA has published a [draft guidance](https://www.fda.gov/media/169118/download?ref=fdaweb.com) entitled “Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Drug Development Programs for Treatment.” The document provides recommendations for clinical drug development for such drugs and it includes advice FDA received at a 12/2017 advisory committee meeting on appropriate patient selection criteria and trial design features, including enrollment criteria and acceptable efficacy endpoints for drugs intended to treat IC/BPS, the agency says.

“Early clinical trials during drug development should focus on well-defined IC/BPS populations with similar clinical features in addition to pain or discomfort localized to the bladder,” the guidance says. “This approach may better inform the selection of clinically meaningful efficacy endpoints and outcomes for future studies.”

Sponsors are also encouraged to assess dosing strategies, including dose-finding, the guidance says. And they should explore multiple efficacy endpoints, and collect safety information during early drug development to help outline design strategies and the selection of clinically meaningful endpoints for later studies.