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December 20, 2012
08:17 EDTACURAcura Pharma submits Investigational NDA
Acura Pharmaceuticals announced that an Investigational New Drug application, or IND, has been filed with the FDA to allow clinical testing of Acura's hydrocodone bitartrate with acetaminophen formulated with Aversion 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.
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August 27, 2014
06:18 EDTACURAcura Pharma awarded NIH grant to fund drug abuse deterrent technology
Acura Pharmaceuticals has been awarded a $300K grant by the National Institute On Drug Abuse of the National Institutes of Health to fund Phase I development of Acura's new, early stage Limitx abuse deterrent technology. The Grant is based on a proposal submitted by the company to advance the development of a self-regulating hydromorphone tablet intended to deter abuse by excess oral consumption of the tablets. The company must complete Phase I development by February 28, 2015. Phase I of the project is intended to optimize the formulation in preparation for clinical testing in Phase II. NIDA funding of Phase II development, for which an application has already been submitted, will be contingent upon Phase I progress, approval of other documents and availability of funds.

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