GLAXO’s ORAL ZOFRAN APPROVED DEC. 31

Executive Summary

GLAXO's ORAL ZOFRAN APPROVED DEC. 31 for "the prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy." FDA approval comes two years and four months after Glaxo submitted an NDA for the 4 mg and 8 mg tablet dosage form of ondansetron. A Zofran injection was approved on Jan. 4, 1991 ("The Pink Sheet" Jan. 7, 1991, p. 3). The indication for Zofran oral differs from that for the I.V. formulation. Zofran I.V. is approved for "the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin." Zofran I.V. sales in the U.S. reached $250 mil. In Glaxo's fiscal 1992 ended June 30 ("The Pink Sheet" Sept. 14, p. 8). The oral dosage form could prove more convenient for many patients, especially if Zofran adds new indications under study by Glaxo. An NDA for treatment of post-operative nausea is pending, and clinical trials are evaluating ondansetron for schizophrenia, memory loss and other central nervous system conditions. The recommended dose of oral Zofran is one 8 mg tablet given three times daily, with the first dose given 30 minutes prior to chemotherapy and subsequent doses every eight hours for up to two days. Most common side effects of oral Zofran in U.S. clinical trials were headache (21%), constipation (7%) and abdominal pain (5%), labeling states. Unlike Zofran I.V., oral Zofran did not cause a significant incidence of diarrhea.