New Formulation Of Zofran Cleared By FDA

A new formulation of Zofran for patients who can't or won't take regular tablets or suppositories has received clearance for marketing from the U.S. Food and Drug Administration (FDA). The new formulation of the oral 5HT3 antagonist antiemetic, known as Zofran ODT (ondansetron) Orally Disintegrating Tablets, uses a novel, freeze-dried technology. The strawberry-flavored tablet disintegrates instantly when placed on a patient's tongue and does not require water to aid in swallowing.

Like regular Zofran (ondansetron HCl) Tablets, Zofran ODT will be indicated for the prevention of nausea and vomiting associated with moderately emetogenic chemotherapy in adults and children (ages 4 and older), and for the prevention of nausea and vomiting associated with radiotherapy in adults. "Nausea and vomiting are frequent side effects of chemotherapy and radiation therapy," said Judy Bryson, director of U.S. medical affairs, oncology, for Glaxo Wellcome Inc. "Administering an oral as opposed to an intravenous 5HT3 prior to chemotherapy is becoming increasingly popular, yet, for many patients, swallowing conventional tablets can be problematic."

The new formulation will be available by prescription the first week of March 1999.

For more information: Glaxo Wellcome Inc., Five Moore Drive, Research Triangle Park, NC 27709, USA.