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FDA Approves Zofran (Ondansetron) For Use in Children as Young as One Month of Age

PHILADELPHIA, PA -- March 29, 2005 -- GlaxoSmithKline today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for ZofranŽ (ondansetron hydrochloride) Injection to prevent nausea and vomiting associated with general anesthesia in children as young as one month of age and nausea and vomiting associated with chemotherapy in children as young as six months of age.

The sNDA was filed on September 28, 2004 and was granted priority review status by the FDA. This new indication makes Zofran the only medication approved to prevent post-operative nausea and vomiting (PONV) and chemotherapy-induced nausea and vomiting (CINV) in infants. Zofran was previously the first product to receive a pediatric indication for the prevention of PONV and CINV in children two years of age and older.

"Nausea and vomiting in young children following surgery or chemotherapy can be very upsetting to patients and their parents," said Kevin Lokay, vice president, Oncology and Acute Care, GlaxoSmithKline. "This new indication further supports the clinical utility of Zofran and its value as a trusted option for preventing these troublesome complications of surgery and chemotherapy in young patients."

Zofran Prevents Vomiting in Pediatric Clinical Trials

In one double-blind, multi-center, placebo-controlled study of 670 pediatric patients aged one month to two years of age undergoing routine surgery under general anesthesia, a single (0.1 mg/kg I.V.) dose of Zofran Injection, administered within five minutes following induction of anesthesia, was significantly more effective than placebo in preventing vomiting. In the placebo group, 28 percent of patients experienced vomiting compared to 11 percent of subjects who received Zofran. Overall, 10 percent of patients given placebo received anti-emetic rescue medication(s) or prematurely withdrew from the study compared to 5 percent of patients who received Zofran. The incidence of adverse events considered possibly related to study medication was similar between Zofran and placebo (1 percent with placebo; 2 percent with Zofran). The most commonly reported related adverse events, agitation and swelling, occurred in less than 1 percent of either group.

The safety and anti-emetic effects of Zofran Injection in the prevention of chemotherapy-induced vomiting were studied in an open-label, multi-center, non-comparative trial of Zofran in 75 pediatric cancer patients aged six months to four years of age receiving chemotherapy that would be expected to result in at least 50 percent of patients experiencing an episode of vomiting if no anti-emetic were administered. Study results showed that 56 percent of patients who received Zofran intravenously over 15 minutes in three doses of 0.15 mg/kg (first dose administered 30 minutes before the start of chemotherapy, the second and third doses administered at four and eight hours after the first dose, respectively) experienced a complete response, defined as no vomiting, no use of rescue medication and no early withdrawal from the study. No serious adverse events were reported in the study. Only one adverse event in the study, a rash, was thought possibly related to treatment with Zofran.


SOURCE: GlaxoSmithKline

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