Wilmington Pharmaceuticals Receives FDA Approval for Orally DisintegratingMetoclopramide Tablet
Wed, 09/09/2009 - 4:26am
Wilmington Pharmaceuticalsannounced today that the FDA has grantedmarketing approval for METOZOLV(TM) ODT (metoclopramide HCl), an orallydisintegrating formulation of metoclopramide for the treatment ofgastroesophageal reflux disease (GERD) and diabetic gastroparesis. Wilmingtonhas licensed METOZOLV ODT to Salix Pharmaceuticals, Inc., a specialtypharmaceutical company with a focus on gastrointestinal disorders. Wilmington Pharmaceuticals designed METOZOLV ODT to improve the deliverymode for patients who have difficulty swallowing pills or liquids due to theirdisease state. Orally disintegrating METOZOLV ODT tablets rapidly… melt on thetongue, 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, theapproval of a patient-friendly formulation of an established drug thataddresses the needs of patients who cannot swallow traditional tablets," Haleysaid. "As developers of rapid-dissolve formulations for proven drugs, weprovide our industry partners with significant potential for commercial gainwithout typical risks, costs, and time commitments associated with new drugdevelopment." Salix Pharmaceuticals will market METOZOLV ODT under a licensing agreementwith Wilmington Pharmaceuticals. METOZOLV ODT is indicated for relievingsymptoms in adults with acute and recurrent diabetic gastroparesis and forshort-term therapy (4-12 weeks) in adults with symptomatic, documented GERDthat fails to respond to conventional therapy. "METOZOLV ODT offers a medically important option to physicians andpatients," said Carolyn Logan, CEO of Salix Pharmaceuticals. "We are delightedto bring a patient-friendly formulation of this widely prescribed product tomarket." "Wilmington Pharmaceuticals has proven to be a very reliable and efficientpartner in the development of this important new dosage form ofmetoclopramide," Logan added.