ZOFRAN APPROVED IN UK FOR PONV

Glaxo has received marketing approval from the UK regulatory authorities for its 5-HT3 antagonist Zofran (ondansetron) as a treatment for post-operative nausea and vomiting. This is the first time that marketing approval has been given for the PONV indication. The registration application was submitted in October 1991.

Glaxo Pharmaceuticals expects to launch Zofran for PONV in the summer, in both tablet and injectable formulations. PONV is experienced by an average of 30% of patients undergoing all types of surgery, and the incidence can increase up to 60%-70% following highly emetic procedures such as gynecological, abdominal and ophthalmic surgery.

The incidence is also different depending on the patient characteristics and the anesthetic used. For example, children, women and the obese appear to have a higher susceptibility to PONV, although the reasons for this have not been fully elucidated. Zofran is not indicated for use in PONV in childrn, but Glaxo is carrying out clinical trials on the safety and efficacy of giving the drug to children who undergo surgery for squint.