The PDUFA Date for Astra Zeneca‘s Brilanta is still a ways off, not until July 20, 2011 but we think it’s safe to call this one an approval. AZN has had it’s problems with this application since the original submission in 2009. Initially rejected by the FDA for a variety of problems including manufacturing issues, their latest CRL only cited a reanalysis of some of the clinical data and required a post marketing safety plan, REMS. We think that AZN has probably solved both issues with the FDA. The earlier approval this year by the European Authorities and the approval earlier this month by the Canadians probably reflects the reanalyzed data. We wouldn’t be surprised if the approval came before the PDUFA Date.
Archive for June 2011
Yes, we know that all of the bells have tolled for Contrave – even the fat lady’s final notes have faded, but we feel compelled to comment on the Orexigen announcement that they have put their plans for Contrave on hold because they failed to convince the FDA that their plan to study the potential cardiovascular effects was sound. Equally interesting to us was the comment made that such action by the FDA challenges the development of obesity drugs in the US.
We have been consistent in our opinion of the three obesity drugs that were before the FDA during the past year. Uniformly, they either didn’t meet the very lenient efficacy requirement or in fact failed it. Recall our cupcake commentary – 5% weight loss over the course of a year for a 200 pound person is the equivalent of one cupcake a week. Remember also, it is all about benefit risk with the FDA. With such a lenient efficacy requirement, it is understandable that the FDA expects a very clean safety profile.
There is a case for the continued evaluation of obesity drugs in the US. With all the reports confiming that we are a society that is becoming more and more obese, dieting and will power don’t seem to be able to control the trend. So how about developing a drug that is as effective as gastric by pass with 25% weight loss not uncommon in the year following surgery. Such a weight loss with the accompanying reduction in co-morbidities associated with obesity may just get the benefit risk to a position that the FDA finds acceptable.
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.