Wednesday, April 21, 2010

FDA to Ask Panel about "abuse-resistant" Acurox

(Dow Jones)--The Food and Drug Administration questioned whether
it was acceptable to subject patients to a known side-effect of an ingredient
placed in a drug being developed by Acura Pharmaceuticals Inc. (ACUR) and King
Pharmaceuticals Inc. (KG)
designed to treat pain while deterring prescription
drug abuse.

The drug, Acurox, was developed to relieve moderate-to-severe pain and
potentially less likely to be abused than other types of prescription pain
medicines.

It contains the active ingredient oxycodone to relieve pain but also contains
niacin, which can cause side effects like skin flushing that the companies say
would help deter abuse of product -- especially if the drug is taken in excess
doses.

Acurox will be reviewed at a joint meeting of the FDA's drug safety and risk
management committee and the anesthetic and life support drugs committee
Thursday.

The FDA said, in a review of the product released Tuesday, that it would ask
the panel "whether it is acceptable to risk adverse reactions such as flushing
in patients in order to produce a product with properties targeted at deterring
misuse and abuse."

However, the panel will also be asked if the presence of niacin in the
product is strong enough to deter abuse of the painkiller given that food and
nonsteroidal anti-inflammatory drugs can be used to minimize the effect of
flushing.

Along with containing niacin, Acurox is also designed to irritate the nasal
passages if drug abusers attempt to snort the product and to form a gel-like
mass when dissolved in water which makes it hard to be administered through a
syringe.

The panel will be asked to vote on whether it thinks Acurox should be
approved. The FDA isn't required to follows its panel's advice but usually
does.

The companies submitted an application for approval of Acurox to the FDA in
December 2008, but the FDA refused to approve the product and issued a
so-called "complete response" letter on June 30, 2009. In September, Acura and
King met with the FDA which agreed to bring the studies involving the product
before an agency advisory committee.

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