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Acura Pharma Submits Investigational New Drug

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Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) today announced that an Investigational New Drug application ("IND") has been filed with the U.S. Food and Drug Administration (FDA) to allow clinical testing of Acura's hydrocodone bitartrate with acetaminophen formulated with Aversion(R) Technology. Clinical testing can commence under the IND 30 days following the IND filing unless questions are raised by the FDA. An open IND is required for Acura to initiate intranasal abuse liability testing in recreational drug users of the crushed drug product. This study is part of a comprehensive development program we intend to complete in anticipation of submitting a 505(b)(2) NDA for our hydrocodone/acetaminophen product in the first half of 2014. The plan also includes: -- a pharmacokinetic study demonstrating dose proportionality and evaluating the food effect; -- a battery of laboratory studies demonstrating extraction, syringing and particle size characteristics; -- a pharmacokinetic study to establish a bridge to a new contract manufacturer; and -- an assessment of the routes of abuse of hydrocodone products. Acura continues to evaluate possible partnering of our Aversion development products with alternative strategic partners.

Posted-In: News FDA


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