Bladder Pain, Interstitial Cystitis And The Move Toward Patient-Focused Drug Development
Patients with the conditions experience the same symptoms, US FDA advisory committee concludes. Industry sponsors had advocated for combined trials, but panel did not agree with firms' recommendations on study duration and outcome measures.
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US FDA is following through on defining interstitial cystitis and bladder pain syndrome as a single condition – a move that runs counter to the trend towards more targeted, mechanistic definitions of disease. But the agency also offers a unique idea for endpoints that are truly personalized.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Advisory committee to vote on whether patients with interstitial cystitis, marked by Hunner's lesions, should be studied separately from the broader, more heterogeneous category of patients with bladder pain syndrome; recommendations could impact Aquinox and Urigen, which have drugs for IC/BPS in clinical development.