Zofran Approved for Prevention of RT Emesis

April 1, 1995

RESEARCH TRIANGLE PARK, NC--Zofran Tablets (ondansetron), from Cerenex Pharmaceuticals, Division of Glaxo Inc., has received FDA approval for a new indication--the prevention of radiation-induced nausea and vomiting. The oral agent, a 5-HT3 antagonist, is currently marketed for prevention of emesis in cancer patients receiving moderately emetogenic chemotherapy.

RESEARCH TRIANGLE PARK, NC--Zofran Tablets (ondansetron), fromCerenex Pharmaceuticals, Division of Glaxo Inc., has receivedFDA approval for a new indication--the prevention of radiation-inducednausea and vomiting. The oral agent, a 5-HT3 antagonist, is currentlymarketed for prevention of emesis in cancer patients receivingmoderately emetogenic chemotherapy.

The specific recommendation is for patients receiving either totalbody irradiation, single high-dose fraction, or daily fractionsto the abdomen. The recommended oral dosage for the new indicationis one 8 mg Zofran Tablet given three times a day. In radiotherapytrials, the most commonly reported side effects of Zofran Tabletswere constipation (6%), headache (5%), and diarrhea (2%).