Asimadoline Side Effects

Asimadoline is a promising new drug under development for the treatment of patients with irritable bowel syndrome (IBS) in whom diarrhea is the predominant symptom (IBS-D). Currently, there is only one drug approved by the US Food and Drug Administration (FDA) to treat IBS-D, and its use is restricted to physicians enrolled in a specific program to treat women with severe IBS-D who have failed to respond to other therapy.

IBS

• The Mayo Clinic estimates that one in five people have IBS but that fewer than half consult their physicians about their symptoms, which commonly include abdominal pain or cramping, bloating, gas, diarrhea and/or constipation and mucusy stool. IBS patients are generally classified by their predominant symptom: IBS with diarrhea (IBS-D), IBS with constipation (IBS-C) and IBS that alternates between diarrhea and constipation (IBS-A).

Prognosis

• According to the Mayo Clinic, IBS is a common disorder of the colon and does not cause permanent damage to your intestines, which may occur with more serious gastrointestinal disorders, such as ulcerative colitis and Crohn's disease. Most people with IBS do not experience severe symptoms and many IBS sufferers can manage their symptoms by monitoring their diet, lifestyle and stress.

Asimadoline

• Asimadoline is a novel therapy that is being developed by Tioga Pharmaceuticals, Inc., to treat patients with IBS-D. In an early clinical trial, Tioga reported that asimadoline signficantly reduced pain, urgency, frequency of bowel movements and bloating compared with placebo (sugar pills) in both men and women. In this trial, asimadoline was said to be generally well tolerated and did not produce any adverse effects related to the dosage being administered. According to Tioga, asimadoline has not raised any safety concerns based on data from early clinical research in more than 1,100 subjects evaluated to date.

FDA Approval

• Before the FDA evaluates data on drugs in development, Phase 3 testing must be completed. Tioga Pharmaceuticals announced that it had begun Phase 3 testing in June of 2010. They will conduct two Phase 3 trials before the FDA has sufficient data to determine whether asimadoline is safe and effective to treat patients with IBS-D.

  [see Press Release]

Side Effects

• Phase 3 testing will provide a good profile of the efficacy of asimadoline and any side effects that may occur during treatment. These side effects will be listed in the drug's product labeling so that physicians and patients are aware of the risks and benefits of therapy with asimadoline.