Shares of Salix Pharmaceuticals (NASDAQ:SLXP) have been rising in anticipation of their upcoming FDA decision, which is due this coming week.
Shares for the company rose as much as 34% since July and on September 11, the FDA is scheduled to decide whether or not to approve the company's Metozolv (metoclopramide) Orally Disintegrating Tablets indicated for the short-term treatment of adults with gastroesophageal reflux and for the relief of symptoms associated with diabetic gastroparesis.
The Salix Pharmaceuticals drug rifaximin was recently granted priority for review by the U.S. Food and Drug Administration, the Morrisville company announced Monday.
Salix already sells rifaximin as a treatment for travelers’ diarrhea. That product, marketed with the name Xifaxan, provided $26.3 million of Salix’s $52.2 million in second-quarter revenue. The company now is seeking FDA approval to market the drug for a different indication.
Priority-review classification is reserved for drugs that either offer the potential for major advances in treatment or may provide treatment where no adequate therapy exists.
Assuming Metozolv ODT is approved and launched this year, the company expects its total product revenue in 2009 to rise 29% to about $230 million (based on a pull-through methodology) or rise 34% to $240 million (based on a sell-in methodology), compared to 2008.
Salix Pharmaceuticals, Ltd. is a specialty pharmaceutical company based in North Carolina focused on acquiring, developing and commercializing prescription drugs used in the treatment of a range of gastrointestinal diseases, which are those affecting the digestive tract.