Acura Pharmaceuticals announced that it met on December 5 with the FDA to review the results of Acura's Study AP-ADF-301, a phase II clinical study in 40 recreational drug abusers assessing the abuse liability of snorting a crushed hydrocodone bitartrate with acetaminophen tablet formulated with Acura's abuse deterrent AVERSION technology. The primary purpose of the meeting was to discuss if the FDA will consider whether the results of Study 301 are acceptable for submission in a New Drug Application. The FDA agreed to further review the study results and supporting data within the context of the meeting discussions and provide a definitive response as to the suitability of Study 301 to be considered in an NDA review, including as part of product labeling. The company and FDA also discussed, among other things, certain inactive ingredients contained in Acura's AVERSION technology, and the company agreed to capture specific adverse events and safety information associated with these ingredients within its remaining planned development program. At this time, the company does not expect the need to run additional clinical studies to provide the additional information requested by the FDA, beyond the pharmacokinetic studies planned but currently on hold.
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