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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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October 16, 2014
06:09 EDTACURAcura Pharma reports FDA denies appeal regarding hydrocodone with acetaminophen
Acura Pharmaceuticals announced that the FDA has denied on procedural grounds Acura's appeal of the position taken by Division of Anesthesia, Analgesia, and Addiction Products, or DAAAP, that abuse by snorting of hydrocodone with acetaminophen products lacks relevance. Relevance is defined in FDA's January 2013 Draft Guidance on the evaluation and labeling of abuse deterrent opioids to be a "known or expected" route of abuse for that product. In a letter decision from the Office of Drug Evaluation II, the FDA indicated that DAAAP's comments and correspondence to date with Acura, as well as the Draft Guidance on abuse deterrent opioids, should be viewed only as recommendations and opinions and do not preclude Acura from completing its clinical development and submitting a New Drug Application for its hydrocodone with acetaminophen product for consideration. FDA further noted that for issues such as abuse-deterrence an Advisory Committee meeting may greatly inform their considerations. The FDA's letter also advised the Company that we may appeal this decision to the next level within the FDA. Acura is assessing its development strategy for its abuse deterrent hydrocodone with acetaminophen program, including the merits of appealing the FDA's decision.

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