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Wilmington Pharmaceuticals Receives FDA Approval for Orally Disintegrating Metoclopramide Tablet
Date:9/9/2009

WILMINGTON, N.C., Sept. 9 /PRNewswire/ -- Wilmington Pharmaceuticals announced today the U.S. Food and Drug Administration (FDA) has granted marketing approval for METOZOLV((TM)) ODT (metoclopramide HCl), an orally disintegrating formulation of metoclopramide for the treatment of gastroesophageal reflux disease (GERD) and diabetic gastroparesis. Wilmington has licensed METOZOLV ODT to Salix Pharmaceuticals, Inc., a specialty pharmaceutical company with a focus on gastrointestinal disorders.

Wilmington Pharmaceuticals designed METOZOLV ODT to improve the delivery mode for patients who have difficulty swallowing pills or liquids due to their disease state. Orally disintegrating METOZOLV ODT tablets rapidly* melt on the tongue, thereby eliminating the need for swallowing pills with water, according to Eugene Haley, founder and CEO of Wilmington Pharmaceuticals.

"We are extremely pleased to have achieved a significant milestone, the approval of a patient-friendly formulation of an established drug that addresses the needs of patients who cannot swallow traditional tablets," Haley said. "As developers of rapid-dissolve formulations for proven drugs, we provide our industry partners with significant potential for commercial gain without typical risks, costs, and time commitments associated with new drug development."

Salix Pharmaceuticals will market METOZOLV ODT under a licensing agreement with Wilmington Pharmaceuticals. METOZOLV ODT is indicated for relieving symptoms in adults with acute and recurrent diabetic gastroparesis and for short-term therapy (4-12 weeks) in adults with symptomatic, documented GERD that fails to respond to conventional therapy.

"METOZOLV ODT offers a medically important option to physicians and patients," said Carolyn Logan, CEO of Salix Pharmaceuticals. "We are delighted to bring a patient-friendly formulation of this widely prescribed pr
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SOURCE Wilmington Pharmaceuticals
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