AstraZeneca today announced that a new formulation for its prescription proton pump inhibitor NEXIUM ® (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.
Nexium works by inhibiting gastric acid secretion in the gut by binding to H-2 receptors.
(NYSE: AZN - News)
AZN closed trading today down 36 cents to 65.22.
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