Nexium receives new FDA approval

A new indication for AstraZeneca's prescription proton pump inhibitor (PPI) Nexium (esomeprazole magnesium) has been approved by the FDA. Nexium is now also indicated for reducing the risk of gastric (stomach) ulcers developing among at risk patients on continuous therapy with non-steroidal anti-inflammatory drugs (NSAIDs). The FDA also issued an approvable letter for the indication of the healing of gastric ulcers associated with NSAIDs therapy.

'NSAIDs play a crucial role in providing relief to many pain sufferers. However potentially serious gastrointestinal side effects are often a deterrent to continue long-term treatment,' says James Scheiman, MD, gastroenterologist at University of Michigan Health System. 'Health care professionals now can offer their patients on NSAID therapy, who may be at risk for developing gastric ulcers, a therapeutic option that may lessen possibility of such stomach injury occurring.'

A total of 1,429 patients, ranging in age from 19 to 89 were evaluated in two separate multi-centre, double-blind, placebo-controlled clinical studies. Patients included in both studies had a chronic condition requiring daily NSAID treatment (including COX-2 selective NSAIDs). They were randomised to treatment with Nexium, 40 mg or 20 mg once daily, or placebo for up to 6 months. Nexium 20 mg and 40 mg demonstrated comparable benefits in providing risk reduction with the proportion of NSAID patients remaining free of gastric ulcers ranging from 95.4% to 96.7% in one study and 94.7% to 95.3% in the second study.

It is estimated that over 100m prescriptions are written for NSAIDs each year in the US. Everyday approximately 30m people worldwide take NSAIDs. NSAIDs, which include such popular pain medications as aspirin, ibuprofen and naproxen, are a common cause of stomach ulcers and have been associated with side effects ranging from stomach upset to potentially life threatening stomach bleeding. In fact, NSAID use leads to more than 103,000 hospitalisations and 16,500 deaths each year in the US.

Beyond its newest indication in the US for the reduction in the occurrence of gastric ulcers associated with continuous NSAIDs therapy in patients at risk for developing gastric ulcers, Nexium is also approved for healing erosive esophagitis. Studies show that up to 94% of patients were healed with Nexium. Most erosions heal in 4 to 8 weeks. Individual results may vary, and only a doctor using endoscopy can determine if erosions to the esophagus have occurred. The drug is also indicated for treating heartburn and other symptoms associated with acid reflux disease.

Nexium has been launched in 89 markets and with strong continued growth in many large markets, is expected to become the leading branded PPI by value in 2005.