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August 15, 2014
06:17 EDTACURAcura announces preliminary discussions held with FDA for acetaminophen tablet
Acura Pharmaceuticals announced preliminary discussions from a meeting held with the FDA regarding the development pathway for Acura's AVERSION hydrocodone with acetaminophen tablet development candidate, which is intended to provide abuse-deterrent features to address abuse by nasal snorting and injection. In a May 2014 letter to Acura, FDA questioned the relevance of abuse of hydrocodone with acetaminophen products by nasal snorting after reviewing clinical and epidemiology data submitted by Acura. The FDA continues to question the relevance of abuse of hydrocodone with acetaminophen products by the intranasal route of administration and suggested additional information may help better inform their decision. The FDA indicated in the discussions that Acura may conduct an additional nasal abuse liability study for its AVERSION hydrocodone with acetaminophen product candidate, the outcomes of which may help inform the relevance decision as well as establish a reduction in drug liking, which was not statistically significant in an earlier Acura study. The FDA requested further time to deliberate on the issues discussed during the meeting before issuing final meeting minutes. Acura intends to review its clinical data from Study AP-ADF-301 to determine whether to proceed with an additional clinical study for its AVERSION hydrocodone with acetaminophen product candidate and to further evaluate options to address the issues of intranasal abuse and drug liking raised by the FDA.
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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 Relevance is defined in FDA's January 2013 Draft Guidance on the evaluation and labeling of abuse deterrent opioids to be a "known or expected" route of abuse for that product.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of Drug Evaluation II, the FDA indicated that DAAAP's comments and correspondence to date with Acura, as well as the Draft Guidance on abuse deterrent opioids, should be viewed only as recommendations and opinions and do not preclude Acura from completing its clinical development and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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