UPDATE 2-FDA denies approval of King, Acura's pain drug

giovedì 2 luglio 2009 17:07

* FDA issues complete response letter to the two cos

* Raises questions on the drug's abuse-deterrent properties

* Cos believe can address issues without additional trials

* Acura shares fall as much as 15 pct, King down 3 pct (Adds analyst comments; updates stock movement)

By Esha Dey

BANGALORE, July 2 (Reuters) - Acura Pharmaceuticals Inc ACUR.O and King Pharmaceuticals Inc KG.N said U.S. health regulators denied approval of their pain drug, Acurox, and raised questions on the potential abuse-deterrent benefits of the drug.

The companies, which were issued a complete response letter by the U.S. Food and Drug Administration, said they expect to respond to the issues raised in the letter without conducting any additional studies.

"This is all that Acurox is, its abuse-deterrent. And now there are questions about what FDA thinks about those benefits. It sounds pretty bad," Biologic Investment Research analyst Kevin McNamara said.

McNamara, who has a "sell" rating on the stock, said it is highly unlikely that the drug might even get approved as a branded generic form of oxycodone.   Continua...