Salix says FDA approved stomach and heartburn drug Print E-mail
By Staff and Wire Reports   
Tuesday, 08 September 2009 03:00

Salix Pharmaceuticals Ltd. said Tuesday the Food and Drug Administration approved marketing of a fast-dissolving drug called Metozolv, which is intended to treat diabetic gastroparesis and heartburn.

The FDA's approval covers 5 milligram and 10 mg tablets of Metozolv ODT. The drug's main ingredient, metoclopramide, has long been used to treat the two conditions in different forms. Salix said the tablets usually take less than a minute to dissolve.

Diabetic gastroparesis is a condition in which the stomach takes too long to clear out food. It is caused by nerve damage. Metozolv was approved as a heartburn treatment for patients who are not helped by other drugs. That approval covers use of the drug for four to 12 weeks, the company said.

People who use the drug for extended periods of time often develop muscle spams and movement disorders. That risk increases the more the patients take and the longer they use the drug, and one study found that 20 percent of patients who use metoclopramide for more than three months develop movement disorders, or dyskinesia.

Other side effects can include sedation, insomnia, depression and anxiety.

Salix acquired the rights to disintegrating Metozolv tablets from Wilmington Pharmaceuticals. It said the drug has patent protection until 2017, and an additional patent is pending that could protect the drug until 2025.

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