The Mutual Recognition Procedure (MRP) for new indications for AstraZeneca's Nexium (esomeprazole) has been finalised. The new indications are for the healing of gastric ulcers and, for patients at risk, the prevention of gastric and duodenal ulcers, associated with non-steroidal anti-inflammatory drug (NSAID) therapy. The company is now awaiting individual national approvals.

According to the company release, Nexium is proven to be fast and effective in healing gastric ulcers in patients taking NSAIDs, including COX-2 selective NSAIDs. In addition, it is proven to be effective in preventing gastric and duodenal ulcers associated with all NSAIDs, including COX-2 selective NSAIDs.

Professor Chris Hawkey, University Hospital, Nottingham and lead investigator of the worldwide Nexium NSAID programme said that the results of Nexium research into the treatment of NSAID-associated upper GI side-effects showed that Nexium is effective in substantially reducing NSAID-associated damage and ulcers.

"The good news is these innovative studies show Nexium can effectively heal gastric ulcers and prevent gastric and duodenal ulcers, associated with long-term NSAID therapy, as well as relieve other painful upper GI symptoms such as epigastric pain, heartburn and acid reflux," he said.

Nexium is an established treatment for gastroesophageal reflux disease (GERD). GERD is a common condition that can significantly impair quality of life. It is characterised by reflux of gastric acid from the stomach into the esophagus, causing upper GI symptoms such as heartburn and acid reflux. Erosive esophagitis (inflammation of the esophagus) is often present.

Nexium belongs to the class of drugs, proton pump inhibitors (PPIs). PPIs work by blocking the production of gastric acid which can irritate the lining of your esophagus, stomach and duodenum (the top end of your small intestine).

Effective control of gastric acid secretion is a key factor in the management of GERD and NSAID-associated upper GI side-effects. Nexium has been shown to provide more effective control of gastric acid secretion than all other PPIs. It works by deactivating the proton (acid) pumps that produce stomach acid. This reduces the amount of acid that is in the stomach, helping to treat heartburn and other symptoms of GERD, the release added.

Regulatory applications for the use of Nexium for the healing of NSAID-associated gastric ulcers and prevention of NSAID-associated gastric and duodenal ulcers in patients at risk, were submitted in the US and other global markets earlier this year. Discussions with these regulatory authorities are ongoing and further approvals are anticipated in the coming months.