Acura Pharmaceuticals and King Pharmaceuticals announced that they have met with the FDA to discuss the FDA’s Complete Response Letter regarding the New Drug Application (NDA) for Acurox (oxycodone HCl and niacin) tablets for the proposed indication of relief of moderate-to-severe pain. The FDA, Acura, and King have agreed to take the NDA to an FDA Advisory Committee to consider the evidence to support the potential opioid abuse deterrent effects of Acurox. The FDA indicated that no new clinical trials are required at this time and has not yet set a meeting date for the Advisory Committee’s review of the NDA. Acura and King do not expect the meeting to be convened before the end of 2009.
Acurox is an investigational, orally administered, immediate release tablet containing oxycodone HCl as its sole active analgesic ingredient. Acurox utilizes Acura’s proprietary Aversion Technology, a composition of commonly used active and inactive ingredients with gelling and aversive properties to provide abuse deterrent features to orally administered drug products. In products that utilize Aversion Technology, extraction of the active ingredient using household solvents (eg, water or alcohol) into a volume and form suitable for IV injection converts the tablet into a viscous gel unsuitable for IV injection and traps the active ingredient in the gel. A combination of functional inactive ingredients in Aversion Technology products discourages nasal snorting by inducing nasal passage discomfort (eg, burning, irritation, and disliking effects) if the tablets are pulverized and snorted. Aversion Technology products also contain niacin, which is intended to induce temporary dysphoric effects (eg, flushing, itching, sweating, chills, headache and a general feeling of discomfort) as increasing numbers of tablets are swallowed above the recommended dose. The clinical significance of Aversion Technology has not been established.
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