ACUROX opinion

The PDUFA Date for ACUROX is June 17, 2011.  ACUROX is the product of Acura Pharmaceuticals which had an agreement with King Pharmaceuticals which was acquired by Pfizer.  The drug is immediate release oxycodone formulated with ACUROX’s Aversion abuse potential technology.  If you recall, this is not the first time around the track for Acura.  It originally presented a similar product for oxycodone with niacin to the FDA Advisory Committee in April of 2009.  The Advisory Committee was less than impressed and voted it down 19-1.  The FDA followed with a CRL in June of 2009.  The company resubmitted the application without niacin at the end of 2010 and got a Priority Review designation.

We see a couple of obstacles standing in the way of approval this time around.  The first is the unique technology.  It is difficult to judge the usefulness of the technology based on the information available.  To our knowledge, there is no other drug approved that uses the Aversion abuse technology.  A second obstacle is proof offered by the company on its website for efficacy.  It cites a study done by an independent chemist in support of the difficulty in extracting oxycodone from the formulation.  The clinical trials appear to have used recreational “snorters” to test the Aversion technology.  It is difficult for us to assess the resourcefulness of recreational “snorters” vs the more hard core drug abusers in overcoming the obstacle imposed by the Aversion technology.  The third and most significant obstacle to the approval of this drug is the FDA request to the company for robust, long term clinical studies to support the label claim.  The company has commented that these studies are too long and too expensive and they will address the usefulness of the Aversion technology in the product labeling.

We don’t think a package insert statement will satisfy the FDA requirement for robust, long term clinical studies.