Sep 10 2009
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 product to market."
"Wilmington Pharmaceuticals has proven to be a very reliable and efficient partner in the development of this important new dosage form of metoclopramide," Logan added.
METOZOLV ODT represents the first approved drug among an array of candidates that Wilmington Pharmaceuticals is reformulating with rapid-dissolve technology. The company identifies well-established drugs to combine with rapid-dissolve delivery technologies and then licenses the drugs to pharmaceutical partners. Wilmington's seasoned pharmaceutical executives lead an integrated network of industry experts who seamlessly execute the diverse strategies required to develop and commercialize each product.
"We take proven drugs and enhance their delivery to increase patient convenience and compliance," said David Burns, Wilmington's vice president of development and manufacturing. "We have assembled an extremely experienced and capable team that has facilitated our success in obtaining approval for METOZOLV ODT within an 18-month time frame, and the team is now developing additional products for approval."