2 firms may get OK for alcoholism shot

Cephalon Inc. and Alkermes Inc. said Wednesday that they may win U.S. approval of their once-a-month Vivitrol shot to fight alcoholism in time for a second-quarter introduction.

The Food and Drug Administration may clear the shot after reviewing laboratory data on Vivitrol's functioning in the body, the companies said in a statement. The FDA must decide on Vivitrol's prescribing information, intended to teach doctors how to use the shot, which helps shape U.S. drug marketing.

Vivitrol sales might reach $15 million next year, Corey Davis, a JP Morgan Securities analyst, said in a note Wednesday. The FDA issued a so-called approvable letter, outlining what work remains on the application, to Alkermes, based in Cambridge, Mass., and Cephalon, based in Frazer, Pa.

"At this time, we are evaluating the FDA's request to determine whether additional preclinical work is necessary," said Rebecca Peterson, an Alkermes spokeswoman, in an e-mailed statement. "We do not anticipate potential preclinical work to impact our timeline for product launch."

Cephalon shares fell 61 cents, or less than a percent, to close at $64.67 on the Nasdaq Stock Market. Alkermes shares fell 9 cents, or less than a percent, to $17.79.

JP Morgan's Davis earlier predicted that the FDA would delay its decision on Vivitrol. The drug's active ingredient is naltrexone. Barr Pharmaceuticals Inc., Tyco International Ltd. and Novartis AG have U.S. approval for naltrexone tablets, according to the FDA's Web site.