Acura: Data From Study 301 is Insufficient According to FDA

Acura Pharmaceuticals, Inc. ACUR today announced the US Food and Drug Administration (FDA) advised the Company that the data from our intranasal abuse liability study AP-ADF-301 (Study 301) for our AVERSION hydrocodone bitartrate with acetaminophen (hydrocodone/APAP) product candidate are insufficient to support an intranasal abuse deterrence claim. The FDA's advice was provided in response to the Company's meeting with the FDA on December 5, 2013 to discuss the results of Study 301. The FDA indicated that a product will have to have an impact on "Drug Liking" to support a claim of abuse-deterrence through a relevant route of abuse. Study 301 failed to achieve a statistically significant reduction in "Drug Liking" (also known as Emax). The FDA's advice also questioned whether the intranasal route is a relevant route of abuse for hydrocodone/APAP products and recommended Acura identify variables that could have impacted the findings from Study 301 before considering or conducting an additional intranasal abuse liability study on our AVERSION hydrocodone/APAP product. Acura previously submitted a report to the FDA on the prevalence of abusing hydrocodone products by intranasal administration and intends to meet with the FDA to discuss the FDA's expectations in this area. Acura's plans for AVERSION hydrocodone/APAP, including a revised projected timeline for submission of the New Drug Application, will be determined following our meeting with the FDA. "We are disappointed that our Study 301 data was insufficient to support an intranasal abuse deterrence claim," said Bob Jones, President and CEO of Acura. "Hydrocodone/APAP is generally recognized as the most widely abused drug and our review of available literature indicates that approximately 18% of the general abuse population abuses these products via snorting. Further, we believe this percentage can reach over 70% in some localized markets. We remain committed to developing our AVERSION opioids products to help address the epidemic of prescription drug abuse gripping our country." About Study 301 Study 301 was a phase II, single-center, randomized, double-blind, 5-period crossover assessment of the abuse liability potential of snorting crushed AVERSION hydrocodone/APAP tablets. Forty subjects with a history of insufflating opioids were randomized into the treatment phase of the study after demonstrating they could adequately distinguish euphoria or "high" (measured as drug liking) between placebo and two different doses of hydrocodone/APAP (the drug discrimination phase). In the blinded treatment phase, fasted subjects snorted a single dose of five different crushed study drugs every 48 hours, using either 10mg or 20mg of hydrocodone bitartrate based on the lowest dose the subject could adequately distinguish in the drug discrimination phase. Study drugs were administered in a randomized crossover design. The primary study drugs were placebo, Generic hydrocodone/APAP, and AVERSION hydrocodone/APAP. Two active control drugs were used to blind the subjects to the different powder volumes of the primary study drugs and provide information on the impact of powder volume and the AVERSION ingredients on drug liking scores. Subjects snorted the crushed study drugs using both nostrils over 5 minutes in a design to visually blind the study drugs. The primary endpoint was the subjects' maximum score (Emax) of their drug like/dislike on a 101-point visual analog scale (VAS) at various intervals following administration, with a score of 0 indicating a strong dislike, 100 a strong like and 50 a neutral response. Secondary endpoints measured on a 101-point VAS scale included the minimum score (Emin) of their drug like/dislike, the subjects' willingness to take drug again, assessment of overall drug like/dislike, and assessment of drug high. Subjects also responded to a 6-point Likert scale for nasopharyngeal and facial side effects associated with the AVERSION technology. Pharmacokinetic blood samples were also collected and analyzed for each subject.