Unmet Medical Needs

The major unmet medical need in the field of prokinetic agents has resulted from the withdrawal of cisapride due to issues with QT prolongation. Cisapride had gained widespread use, primarily for the treatment of GERD, but also in the treatment of a wide range of GI disorders including ileus, functional dyspepsia, constipation, and IBS, thus leaving a gap in the pharmacopoeia. The need for a prokinetic agent continues, with a corresponding increased use of metoclopramide, although the adverse events associated with this agent, primarily dyskinesias, are considered unacceptable for most patients. Cholinergic modulators are not sufficiently tolerated for chronic use in outpatients and the efficacy of both motilin and DA receptor agonists have so far failed to convince the clinical community of their usefulness. The opportunity for a safe and effective prokinetic agents remains in the treatment of GERD, postoperative ileus, constipation, and potentially dyspepsia and IBS.

For emesis, the introduction of the NK1 receptor antagonist aprepitant has improved on the prophylactic treatment and control of nausea and vomiting already offered by the 5HT3 receptor antagonists. Despite this advance, many patients on chemotherapy develop problematic nausea and vomiting, particularly in the period beyond the first 24 h postdose, a phenomenon known as delayed emesis.

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