New Prescription Metoclopramide Tablet Wins FDA Approval

By Jim Greene

Published on September 22, 2009

A new prescription tablet that melts in the mouth was recently approved by the Food and Drug Administration (FDA) for treatment of acid reflux and other conditions, according the manufacturer. This is despite recent lawsuits filed against the makers of Reglan (a form of metoclopramide) that allege the drug is associated with an increased risk of the development of muscle disorders.

Salix Pharmaceuticals, Ltd., announced earlier this month that it received approval to sell METOZOLV^TM ODT, an orally disintegrating tablet form of metoclopramide HCl, used to treat symptomatic gastroesophageal reflux disease (GERD), diabetic gastroparesis, and other gastrointestinal conditions.

The company expects to have the new product distributed to pharmacies by November.

The availability of metoclopramide as an orally disintegrating table is a big boon for GERD patients, according to Ronnie Fass, M.D., University of Arizona professor of internal medicine, who said that some patients have trouble swallowing. He also noted the superior portability when compared with injected or oral liquid forms.

Metoclopramide, available under the trade name Reglan, has been the subject of numerous lawsuits since it was linked to tardive dyskinesia, a neurological syndrome characterized by repetitive involuntary purposeless movements. The medication is recommended for short-term treatment (four to 12 weeks), but attorneys for tardive dyskinesia victims have said that doctors and patients have not been properly informed of the limits, resulting in overmedication and permanent damage to patients who used the drug.

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