Efficacy of an ondansetron orally disintegrating tablet: A novel oral formulation of this 5-HT3 receptor antagonist in the treatment of fractionated radiotherapy-induced nausea and emesis

A significant number of patients who are receiving radiotherapy experience the distressing side effects of emesis and nausea. Although prophylactic an tiemetics are often given to patients who are receiving single-fraction, hi gh-dose radiotherapy to the abdomen, a survey has revealed that antiemetic prophylaxis is not routinely offered to those receiving fractionated radiot herapy. Hence there is a need for an effective treatment of emesis for use in this group of patients. Ondansetron is an effective and well-tolerated a ntiemetic, which is used for the prevention of both chemotherapy and radiot herapy-induced emesis and nausea. This agent has been developed as a novel freeze-dried oral formulation. Ondansetron orally disintegrating tablets (o ndODT) disperse rapidly when placed on the tongue. As the tablet does not n eed to be swallowed with water, it is a particularly useful formulation for patients who have difficulty with swallowing or who do not feel able to dr ink. This study was undertaken to investigate the efficacy of ondODT in the trea tment of established emesis and nausea induced by radiotherapy. Two doses o f ondODT, 8 mg and 16 mg, were compared with placebo in patients who develo ped emesis and/or moderate/severe nausea after receiving fractionated radio therapy to sites located between the thorax and the pelvis. The study showed that ondODT was clinically superior to placebo in treating emesis and nausea successfully over a 12-hour period after taking the medi cation. There were no statistically significant differences between the two doses of ondODT. In the 2 hours after taking the study medication, patient s who received ondODT (8 mg and 16 mg) had significantly fewer emetic episo des compared with those who received placebo. They also experienced signifi cantly less nausea. In conclusion, ondODT 8 mg is effective in the treatment of radiotherapy-in duced emesis and nausea and provides an effective alternative to the conven tional ondansetron tablet.