FDA approves Salix’s Metozolv ODT

RALEIGH, N.C. The Food and Drug Administration has given marketing approval to a drug for treating gastroesophageal reflux disease.

Salix Pharmaceuticals announced Tuesday the approval of Metozolv ODT (metoclopramide hydrochloride). The drug, available in the 5-mg and 10-mg strengths, is an orally disintegrating tablet designed relieve symptoms of diabetic gastroparesis and symptomatic documented GERD.

“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,” University of Arizona professor of internal medicine Ronnie Fass said in a statement. “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.”