Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The Food and Drug Administration (FDA) has accepted the complete response from Salix Pharmaceuticals for its orally disintegrating tablet (ORT) form of metoclopramide called Metozolv, and says it has granted a Prescription Drug User Fee Act (PDUFA), which authorizes the FDA to collect fees from companies that produce certain human drug and biological products, for September 11, 2009. Salix is seeking approval for its drug in the treatment of short-term therapy (4-12 weeks) for adults with symptomatic, documented gastroesophageal refulx (GERD or heartburn) who fail to respond to conventional therapy, and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (delayed emptying of the stomach).

Earlier this year the FDA ordered all makers of metoclopramide to provide a risk evaluation and mitigation strategy (REMS) following reports linking the drug to a serious condition in which a person develops involuntary movements of his muscles known as Tardive Dyskinesia. Those taking the medication for more than 12 weeks, elderly patients, and women are at an increased risk of developing the severe adverse reaction. There is no know cure for Tardive Dyskinesia and symptoms may persist even after the medication has been discontinued.

As a result of the REMS, the FDA elevated the warnings to a boxed warning on package inserts of metoclopramide warning of the risks associated with long-term use. Metoclopramide is perhaps most known in the U.S. by the brand name Reglan. An estimated 2 million American use some form of metoclopramide.

Source: Seeking Alpha

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• FDA warns makers of acid reflux drug to change warning label
• Salix stock soars despite FDA warning letter
• New GERD, gastroparesis treatment uses fast-dissolve technology

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