Tioga announced agreement with the FDA regarding a Special Protocol Assessment on its Phase 3 trial for asimadoline for the treatment of patients with diarrhea-predominant irritable bowel syndrome (D-IBS). The SPAs represent agreement with the FDA on the design, execution and analysis of the two planned Phase 3 trials required for product registration. Tioga and the FDA agreed upon the patient population to study; dosage; primary and secondary endpoints and their analyses; inclusion and exclusion criteria; study duration; and evaluations to be performed during the studies, among other items.
Asimadoline is an orally administered small molecule that is a highly selective, peripherally restricted, kappa opioid receptor agonist.
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