Acura Pharmaceuticals,
Inc. 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.
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