FDA Approves New Formulation For NEXIUM

Main Category: GastroIntestinal / Gastroenterology
Article Date: 25 Oct 2006 - 0:00 PDT

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AstraZeneca (NYSE: AZN) today announced that a new formulation for its prescription proton pump inhibitor NEXIUM (R) (esomeprazole magnesium) has been approved by the US Food and Drug Administration (FDA). NEXIUM For Delayed-Release Oral Suspension is now approved for the treatment of GERD, including symptomatic gastroesophageal reflux disease, healing and maintenance of healing of erosive esophagitis (EE), and risk reduction of NSAID-associated gastric (stomach) ulcers.

Each packet of NEXIUM For Delayed-Release Oral Suspension contains either 20 mg or 40 mg of esomeprazole, the same active ingredient used in NEXIUM Delayed-Release Capsules. The esomeprazole granules and inactive granules used in this formulation are mixed with water to form a suspension and are given by oral, nasogastric or gastric administration.

"Some patients with acid-related diseases have difficulties swallowing their oral medication when it is a solid pill," said Doug Levine, M.D., Executive Director, Clinical Development Leader for NEXIUM. "This new prescription option to swallow an oral suspension of NEXIUM or to have it administered via a stomach tube provides these patients with an alternative method of administration that they can take instead of the NEXIUM capsule."

The new formulation of NEXIUM For Delayed-Release Oral Suspension will be available in the first quarter of 2007.

About NEXIUM(R) (esomeprazole magnesium) Delayed-Release Capsules and For Delayed-Release Oral Suspension.

NEXIUM is approved for treating frequent, persistent heartburn and other symptoms associated with acid reflux disease as well as healing erosive esophagitis. Most erosions heal in four to eight weeks. Individual results may vary, and only a doctor can determine if erosions to the esophagus have occurred. Symptom relief does not rule out the existence of other serious stomach conditions.

NEXIUM is also indicated for reducing the risk of gastric (stomach) ulcers developing among at-risk patients on continuous non-steroidal anti- inflammatory drug (NSAID) therapy. Patients are considered to be at risk if they are 60 and over, or if they have a history of previous stomach ulcer.

The most common side effects of NEXIUM are headache, diarrhea and abdominal pain. For full prescribing information for NEXIUM please visit http://www.nexium-us.com.

About AstraZenceca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture, and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology, and infection products. In the United States, AstraZeneca is a $10.77 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

AstraZeneca
http://www.astrazeneca-us.com