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news.Tioga Pharmaceuticals has received fast track status for its experimental compound asimadoline from the US Food and Drug Administration (FDA) as a treatment for the patients who are suffering from diarrhea-predominant irritable bowel syndrome (D-IBS).
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The company is organizing a multi-center Phase 3 trial investigating asimadoline in D-IBS, conducted under a Special Protocol Assessment agreement with the FDA for US registration.
Tioga Pharma chairman and CEO Stuart Collinson said the FDA’s granting of fast track designation for asimadoline signals the agency recognizes that diarrhea-predominant irritable bowel syndrome is a serious illness and that patients lack a safe and effective therapy.