FDA says Salix marketing materials for drug Metozolv are misleading

Morrisville-based Salix Pharmaceuticals made misleading claims about the risks associated with its acid-reflux drug Metozolv in certain marketing promotions, the Food and Drug Administration has ruled.

The FDA issued a warning letter to Salix saying the marketing materials "are false or misleading because they omit and minimize risk information, broaden the indication of Metozolv ODT, and contain unsubstantiated comparative and other claims ... These violations are concerning from a public health perspective because they suggest that Metozolv ODT is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience, and encourage use in circumstances other than those for which the drug has been shown to be safe and effective."

Salix received regulatory approval to market Metozolv in September and, at the time, projected annual sales could reach $50 million.

The drug treats diabetic gastroparesis, a stomach ailment that afflicts about 5 million diabetics. Metozolv also can treat gastroesophageal reflux disease, or GERD, a more serious form of acid reflux.

Metozolv is the first fast-dissolving version of the drug metoclopramide - it melts on the tongue - providing a better option for patients who have trouble swallowing or don't have water available.

In anticipation of Metozolv's approval, last summer Salix added 64 salespeople to promote the drug - as well as other Salix products - to physicians.

Salix acquired the worldwide marketing rights to Metozolv in September 2007 from Wilmington Pharmaceuticals of Wilmington.

Last week, Salix received regulatory approval to expand the marketing of its best-selling drug Xifaxan to patients suffering from serious liver disease.

Salix shares, which have more than tripled in the past year, rose $1.74 today to close at $37.41.