Wilmington Pharmaceuticals Receives FDA Approval for Orally Disintegrating Metoclopram...(ODT (metoclopramide HCl) is indicated as...)

Date:9/9/2009

ODT (metoclopramide HCl) is indicated as short-term therapy for adults with symptomatic, documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (diabetic gastric stasis) in adults. Therapy should not exceed 12 weeks in duration. METOZOLV ODT is contraindicated in patients with intestinal obstruction, hemorrhage, or perforation; pheochromocytoma; known sensitivity or intolerance to metoclopramide; epilepsy; or are receiving concomitant medications with extrapyramidal reactions. METOZOLV ODT should be used with caution in patients showing acute dystonic reactions, drug-induced Parkinsonism, or other extrapyramidal symptoms; neuroleptic malignant syndrome; with a prior history of depression; hypertension; congestive heart failure and ventricular arrhythmia. Patients may experience withdrawal symptoms after stopping the use of METOZOLV ODT.

In clinical studies, the most frequently reported adverse events (greater than or equal to 2% occurrence) were headache, nausea, fatigue, somnolence, and vomiting.

About Wilmington Pharmaceuticals

Wilmington Pharmaceuticals develops and out-licenses patient-friendly, fast-dissolving formulations of established medications to treat pain, cardiac conditions, and central nervous system conditions. The company engages a highly skilled alliance of experts in clinical, regulatory, manufacturing, and other key areas to achieve rapid and cost-effective approval and commercialization of its products. This unique corporate model minimizes regulatory risks while maximizing economic opportunity (www.wilmingtonpharma.com).

About Salix Pharmaceuticals

Salix Pharmaceuticals, Inc., headquartered in Morrisville, North
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