1st Apr 2005 14:30
AstraZeneca PLC01 April 2005 FDA APPROVES INTRAVENOUS FORMULATION FOR NEXIUM(R) AstraZeneca today announced that a new administration formulation for itsprescription proton pump inhibitor NEXIUM (R) (esomeprazole magnesium) has beenapproved by the US Food and Drug Administration (FDA). NEXIUM I.V. is nowapproved as an intravenous infusion or injection for the short-term treatment(up to 10 days) of gastroesophageal reflux disease (GERD) patients, with ahistory of erosive esophagitis, who are unable to take capsules. NEXIUM(R) I.V. (esomeprazole sodium) for injection is administered once daily aseither a 10 to 30 minute intravenous infusion or by intravenous injection (noless than 3 minutes). Treatment is given for up to 10 days and does not requirean in-line filter. Hospitalised patients with GERD are often unable to take their oral medication.The availability of NEXIUM in an intravenous formulation provides these patientswith an effective alternative route of administration that they can tolerateeasily. The approval of NEXIUM I.V. was based, in part, on the findings of fourmulti-centre, open-label, two-period crossover studies. These studies comparedthe pharmacodynamic efficacy of the intravenous formulation with NEXIUMdelayed-release capsules at corresponding doses of 20 mg and 40 mg in GERDpatients with or without a history of erosive esophagitis. They demonstratedthat, after 10 days of once-daily administration, NEXIUM I.V. 20 mg and 40 mgare similar in their ability to suppress acid to the corresponding oral dosageform of NEXIUM. There were no relevant changes in acid suppression when switching betweenintravenous and oral dosage forms. NEXIUM (delayed release capsules) is indicated for treating frequent, persistentheartburn and other symptoms associated with acid reflux disease. The drug wasrecently approved for reducing the risk of gastric (stomach) ulcers developingamong at risk patients on continuous NSAID therapy. It also is approved forhealing erosive esophagitis. Studies show that up to 94 percent of patientswere healed with NEXIUM. Most erosions heal in 4 to 8 weeks. NEXIUM I.V. formulation was first approved via the European Mutual RecognitionProcess in August 2003 and launches in Europe are ongoing. NEXIUM capsuleshave been launched in 89 countries. Worldwide NEXIUM sales totalled $3.9billion in 2004, with US sales reaching $2.7 billion. 1 April 2005 Media Enquiries: Edel McCaffrey, Tel: +44 (0) 207 304 5034 Steve Brown, Tel: +44 (0) 207 304 5033 Investor Relations: Jonathan Hunt, Tel: +44 (0) 207 304 5087 - ends - This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
Astrazeneca