Acura Pharmaceuticals (ACUR) Says FDA Continues to Question Hydrocodone with Acetaminophen Tabs

August 15, 2014 10:18 AM

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Acura Pharmaceuticals (NASDAQ: ACUR) preliminary discussions from a meeting held with the U.S. Food and Drug Administration (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 ...

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