Acura Pharmaceuticals, Inc.
) 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
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,
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.
). While Supernus is a Zacks Rank #1 (Strong Buy) stock, Actavis
and Akorn are Zacks Rank #2 stocks.
ACTAVIS INC (ACT): Free Stock Analysis Report
ACURA PHARMACT (ACUR): Get Free Report
AKORN INC (AKRX): Free Stock Analysis Report
SUPERNUS PHARMA (SUPN): Free Stock Analysis
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