Salix Pharmaceuticals, Ltd. announced the US Food and Drug Administration (FDA) has granted marketing approval for Metozolv ODT (metoclopramide HCl) 5mg and 10mg orally disintegrating tablets. Metozolv ODT is indicated for the relief of symptoms in adults associated with acute and recurrent diabetic gastroparesis and for the treatment of short-term therapy (4-12 weeks) for adults with symptomatic documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy.
"Metozolv ODT is the first available treatment for both diabetic gastroparesis and symptomatic documented GERD that offers physicians and patients the similar safety and efficacy of metoclopramide with the added convenience of an orally disintegrating tablet formulation," said Ronnie Fass, MD, FACP, FACG and Professor of Internal Medicine at the University of Arizona. "Patients with diabetic gastroparesis and symptomatic documented GERD may have trouble adhering to treatment because of difficulty swallowing, the need for treatment when they do not have water available, or the need for a portable way to take medication. Metozolv ODT, which rapidly melts on the tongue, gives these patients a new choice that may be more convenient than traditional metoclopramide tablets."
"The addition of Metozolv ODT to Salix's expanding GI-specialty product portfolio provides physicians and patients an innovative treatment choice that may offer improved convenience over traditional metoclopramide therapy," said Bill Forbes, Pharm.D., senior vice president, research and development, chief development officer, Salix Pharmaceuticals. "Diabetic gastroparesis and symptomatic documented GERD are growing health issues among adults in the United States. Bringing Metozolv ODT - the first commercially available orally disintegrating form of metoclopramide for the relief of diabetic gastroparesis and symptomatic gastroesophageal reflux to market - demonstrates Salix's commitment to meeting the unmet GI treatment needs of physicians and patients. We anticipate Metozolv ODT should be available for physicians and patients during November 2009."
Salix acquired the world-wide marketing rights for the orally disintegrating formulation of metoclopramide from Wilmington Pharmaceuticals in September 2007. Salix has entered into a separate agreement with Catalent Pharma Solutions to supply Metozolv ODT, which incorporates Catalent's Zydis, the fastest disintegrating oral tablet available. Metozolv ODT has patent protection until 2017, and additional patent protection pending that, if issued, could provide patent protection until 2025.
Salix Pharmaceuticals, Ltd., headquartered in Morrisville, NC, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases.