King Pharmaceuticals, Inc. (KG) and partner Acura Pharmaceuticals, Inc. (ACUR) recently announced the submission of a new drug application (NDA) for their opioid candidate, Acurox. The companies are seeking US Food and Drug Administration (FDA) approval for the use of Acurox (without niacin) for providing relief from moderate to severe pain.

King Pharma and Acura had also submitted a new drug application seeking approval for Acurox (with niacin) for which the companies received a Complete Response Letter (CRL) on June 30, 2009. Based on discussions with the FDA, King Pharma and Acura submitted the NDA to an FDA advisory panel. However, earlier this year, the FDA panel voted that they did not have sufficient evidence to support the approval of Acurox for the treatment of moderate to severe pain. King Pharma intends to provide an update on the regulatory status of its Acurox (with niacin) tablet shortly.

King Pharma's agreement with Acura relates to the licensing, development, and commercialization of immediate release (IR) pain medicines utilizing Acura's Aversion (abuse-deterrent) technology. The agreement covers the US, Canada, and Mexico. The companies will initially focus on the development and commercialization of four immediate release opioid analgesic products including Acurox, Vycavert and Acuracet