(Adds details, background, analyst comment; updates share
By Vrinda Manocha
Aug 26 Acura Pharmaceuticals Inc said a
painkiller made with its abuse-deterrent technology did not show
statistically significant results in reducing likability among
abusers, sending its shares down as much as 34 percent in
The mid-stage study showed that Acura's tablet, being tested
for potential abuse by snorting, had a slightly lower measure of
liking when compared with the generic hydrocodone/acetaminophen
The company said it expects a delay in the submission of a
marketing approval application for Aversion H&A, its most
advanced drug in development.
MLV & Co analyst Graig Suvannavejh said the drug could still
get approval but potential partners could offer less because it
has not shown to reduce the potential for abuse.
Suvannavejh said the company could include in the label
positive data from secondary goals.
The trial showed the subjects disliked taking the drug at
some point in the treatment.
Acura said there were no serious adverse events reported in
The company said it did not expect to conduct additional
nasal abuse studies though it is yet to meet with the U.S. Food
and Drug Administration to discuss the results.
The drug, which contains hydrocodone bitartrate and
acetaminophen, was earlier developed by Pfizer Inc. The
combination is also sold under the brand name of Vicodin by
Acura's technology, titled Aversion, consists of inactive
ingredients which form a gelatinous mixture when the tablets are
dissolved for injecting, or cause a burning sensation when the
tablets are snorted.
Acura's pain drug Oxecta, generically known as oxycodone
HCl, using the Aversion technology was approved by the FDA in
Shares of the company were down 20 percent at $1.50 in
trading after the bell.
(Editing by Don Sebastian)