Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Salix Pharmaceuticals’ new gastrointestinal disorder treatment Metozolv (metoclopramide) OTC (orally disintegrating tablet ) utilizes Zydis, a fast-dissolve technology made by Catalent Pharam Solutions. Zydis is a unique, freeze-dried oral solid dosage form that can be swallowed without water because it dissolves instantly on the tongue in less than three seconds, according to Catalent. This delivery method translates to dosing convenience and ease of administration that makes taking medication easier for patients.

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The medication metoclopramide, used in the treatment of some gastrointestional conditions, has received much press lately. Earlier this year the drug fell under a black box warning by the Food and Drug Administration (FDA) after studies showed that patients who took the prescription medication were at high risk of experiencing involuntary movements of their face, hands and torso. The condition, known as Tardive Dyskinesia, is a debilitating disorder that often doesn’t go away even after the offending medication has been discontinued. The result has been measured in countless lawsuits against manufacturers of metoclopramide.

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Salix Pharmaceuticals, Ltd., makers of medicines for various gastrointestinal ailments, has received marketing approval from the Food and Drug Administration (FDA) for Metozolv ODT for the treatment of both diabetic gastroparesis and symptomatic documented GERD. Metozolv ODT is an orally disintegrating metoclopramide tablet. Metoclopramide was previously only available in the United States in a pill form under the brand name Reglan.

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Salix Pharmaceuticals plans to increase its sales force by 60 percent in anticipation of approval by the Food and Drug Administration (FDA) for the drug maker’s new treatment for gastroparesis. The FDA recently accepted the complete response from the Morrisville, North Carolina-based pharmaceutical company for its orally disintegrating tablet (ORT), a form of metoclopramide called Metozolv, and has granted a Prescription Drug User Fee Act (PDUFA) for September 11, 2009. A PDUFA authorizes the FDA to collect fees from companies that produce certain human drug and biological products.

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The Food and Drug Administration (FDA) has accepted the complete response from Salix Pharmaceuticals for its orally disintegrating tablet (ORT) form of metoclopramide called Metozolv, and says it has granted a Prescription Drug User Fee Act (PDUFA), which authorizes the FDA to collect fees from companies that produce certain human drug and biological products, for September 11, 2009. Salix is seeking approval for its drug in the treatment of short-term therapy (4-12 weeks) for adults with symptomatic, documented gastroesophageal refulx (GERD or heartburn) who fail to respond to conventional therapy, and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (delayed emptying of the stomach).

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