ACUR: Submits NDA to FDA for Acurox(R) Tablets
Submitted By Knobias ClipReport
ACUR: Submits NDA to FDA for Acurox(R) Tablets
By Fain Hughes, fhughes@knobias.com
Acura Pharmaceuticals, Inc. (ACUR) and King Pharmaceuticals, Inc. (KG) announced that Acura has submitted a New Drug Application (NDA) for Acurox(R) (oxycodone HCl/niacin) Tablets to the FDA including a request for priority review.
Acurox, a patented, orally administered, immediate release tablet containing oxycodone HCl as its sole active analgesic ingredient, has a proposed indication for the relief of moderate to severe pain. Acurox utilizes Acura’s patented Aversion(R) Technology, which is designed to deter misuse and abuse by intentional swallowing of excess quantities of tablets, intravenous injection of dissolved tablets and nasal snorting of crushed tablets.