FDA Issues Guidance on Bladder Pain Syndrome Trial Designs

Trials for interstitial cystitis and bladder pain syndrome (IC/BPS) should include patients with at least a six-month history of constant bladder pain, according to a new draft guidance issued by the FDA.

The guidance recommends improvement of both bladder pain and urinary tract symptoms as a primary endpoint. The agency also says that using a single primary effectiveness endpoint may be appropriate, for example, if the drug is not expected to improve lower urinary tract symptoms.

Comments on the draft are due by Feb. 3, 2020.