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

Salix Pharmaceuticals plans to increase its sales force by 60 percent in anticipation of approval by the Food and Drug Administration (FDA) for the drug maker’s new treatment for gastroparesis. The FDA recently accepted the complete response from the Morrisville, North Carolina-based pharmaceutical company for its orally disintegrating tablet (ORT), a form of metoclopramide called Metozolv, and has granted a Prescription Drug User Fee Act (PDUFA) for September 11, 2009. A PDUFA authorizes the FDA to collect fees from companies that produce certain human drug and biological products.

Salix hopes to gain full FDA approval to market Metozolv as a short-term therapy (4-12 weeks) for adults with symptomatic, documented gastroesophageal reflux (GERD or heartburn) who fail to respond to conventional therapy, and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis, or delayed emptying of the stomach. Salix currently has 96 salespeople and wants to hire and additional 64 people to its sales force this year to help push the new product.

Drugs for such gastrointestinal ailments as gastroparesis are few and far between and not without their issues. It remains to be seen if when Metozolv hits the market, it will carry the same black box warning already on Reglan, an oral tablet form of metoclopramide that is swallowed. The boxed warning came after it was revealed that long-term use of the drug was linked to a serious involuntary movement disorder known as Tardive Dyskinesia. There is no known cure for the condition, and symptoms may persist even after the medication has been discontinued.

Source: The News & Observer

Related posts:

• Salix receives FDA approval to market new metoclopramide drug
• Salix metoclopramide drug moves closer to FDA approval
• New GERD, gastroparesis treatment uses fast-dissolve technology
• Metoclopramide can diminish quality of life
• Treatments available for drug-induced Tardive Dyskinesia

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