Acura Pharmaceuticals, Inc. (ACUR) suffered a pipeline setback recently with pain drug, hydrocodone bitartrate with acetaminophen tablet using the company’s AVERSION technology (AVERSION H&A), failing to meet the primary endpoint in a mid-stage study.
Acura presented top-line results from a phase II study (Study AP-ADF-301) which was conducted on 40 recreational drug abusers to evaluate the abuse liability of snorting crushed AVERSION H&A.
While the numeric mean maximum drug liking (Emax:72.1) for AVERSION H&A was lower compared to a generic hydrocodone/acetaminophen tablet (Emax: 75.6), the results were not statistically significant.
As far as secondary endpoints were concerned, AVERSION H&A's mean minimum liking (Emin:40.2) was below generic H&A’s mean minimum liking (Emin:50.4). This was a statistically significant difference. The mean minimum drug liking was also statistically significant with that for AVERSION H&A and generic H&A being 40.2 and 48.8, respectively.
The Overall Drug Liking score (:ODL) was lower for AVERSION H&A compared to generic H&A (52.7 versus 71.0). The Take Drug Again assessment (TDA) for AVERSION H&A was also lower at 45.1 compared to 71.0 for generic H&A. Acura reported no serious adverse events.
AVERSION H&A’s failure to meet the primary endpoint is disappointing as it is the most advanced candidate in Acura’s pipeline. Acura is looking to study the results further and intends to meet with the FDA to discuss the data. With the study failing to achieve statistical significance on the primary endpoint, Acura is currently anticipating a delay in its timeline for filing a new drug application. Earlier, the company had guided towards the submission of a new drug application in the first half of 2014. However, the new timeline can now only be determined once the meeting with the FDA takes place. Acura believes it will not be required to conduct additional nasal abuse like/dislike studies.
Acura currently carries a Zacks Rank #2 (Buy). Other companies that look well-positioned include Supernus Pharmaceuticals, Inc. (SUPN), Akorn, Inc. (AKRX) and Actavis, Inc. (ACT). While Supernus is a Zacks Rank #1 (Strong Buy) stock, Actavis and Akorn are Zacks Rank #2 stocks.
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