FDA Questions Abuse-Deterrent Hydrocodone/Acetaminophen Combo Tablet
Agency asks for additional clinical trial
In May 2014, the FDA questioned the relevance of purported abuse of hydrocodone-with-acetaminophen products by nasal snorting after reviewing clinical and epidemiology data submitted in support of such a product candidate designed with proprietary aversion technology.
The new technology contains polymers that cause the drug to gel when dissolved; it also contains compounds that irritate the nasal passages.
In recent discussions with the product’s developer (Acura Pharmaceuticals), the FDA continued to question the relevance of abuse of hydrocodone/acetaminophen products by the intranasal route of administration and has suggested that additional information may help better inform its decision.
The FDA indicated in the discussions that Acura should conduct an additional nasal-abuse liability study for its aversion-technology hydrocodone/acetaminophen product candidate, the outcomes of which may help inform the agency’s relevance decision as well as establish a reduction in drug liking, which was not statistically significant in an earlier investigation (Study AP-ADF-301).
Acura Pharmaceuticals has announced that it intends to review its clinical data from Study AP-ADF-301 to determine whether to proceed with the additional clinical trial of its aversion-technology hydrocodone/acetaminophen product candidate and to further evaluate options to address the issues of intranasal abuse and drug liking raised by the FDA.
In June 2011, the agency approved Acura’s oxycodone hydrochloride immediate-release tablets, which incorporate aversion technology. The company has a development pipeline of additional aversion-technology products containing other opioids.
Source: Acura Pharmaceuticals, Inc.; August 15, 2014.