King Pharma, Acura plan new drug applicaion for Acurox tablets

The companies expect to submit in early 2011.

King Pharmaceuticals and Acura Pharmaceuticals are planning to develop and submit a new drug application (NDA) for Acurox (oxycodone HC1) tablets (without niacin) intended to relieve moderate to severe pain and introduce limits and impediments to potential abuse via nasal snorting of crushed tablets and intravenous injection of dissolved tablets.

Both entities said that on April 22, 2010 at a joint advisory committee meeting, the Federal Drug Administration (FDA) questioned the effectiveness of niacin included in the current Acurox formulation but cited no concerns with the snorting and intravenous abuse limiting features of the product.

King Pharmaceuticals and Acura are also planning to develop and submit NDAs for two additional immediate release opioid analgesic products utilising Acura's proprietary Aversion Technolog: Vycavert (hydrocodone bitartrate/acetaminophen) tablets and Acuracet (oxycodone HCl/acetaminophen) tablets.

Like Acurox, these additional product candidates are patent protected compositions comprising a mixture of active and inactive ingredients intended to relieve pain and introduce limits and impediments to nasal and intravenous abuse.