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FDA to Weight Loss Drug Developers: “Drop Dead!!”


In just the last few months the FDA shot down applications from three new weight loss drugs
and removed one from the market that was previously approved. A month ago, based on
analysis of these actions, I predicted it will take 10 years for a new weight loss drug to be
approved by the FDA
. The latest action by the FDA makes me more confident than ever, in this
prediction.

A sensational action by the FDA to cripple development of new weight loss drugs came
about two weeks ago. The FDA denied approval to the weight loss drug candidate Contrave,
a combination of two medications. Both of the drugs in the combination pill are presently in
use and were FDA approved decades ago for indications other then weight loss. One of the
drugs Naltrexone, is used to treat opiate drug overdoses and the other bupropion HCL is used
to treat depression. Given the long history of safety of both drugs it would seem surprising
the FDA would reject the combination of these drugs on grounds of safety concerns, which
was what happened. Making the FDA rejection even more astounding is that just a month
before, a majority of members of the FDA’s own Endocrinologic and Metabolic Drugs Advisory
Committee, gave a thumbs-up to Contrave. In almost all previous instances where the Advisory
Committee gives their green light to a new drug candidate, the FDA has followed through with
an approval. I can hardly imagine a clearer way for the FDA to say “Drop Dead!!” to all those
seeking to get approval for a new weight loss medication.

Michael Narachi, CEO of Orexigen the maker of Contrave, is quoted as saying he “was
surprised and extremely disappointed with the agency’s (FDA’s) request”, a request which
essentially ended any chance of getting approval for his company’s weight loss drug. My advice
Michael, is to move on with your company and find another drug class to work on. Maybe
something to smooth away skin wrinkles or relieve constipation. I’m sure you will have a lot
more success. In the meanwhile, the epidemic of diabetes type 2, cardiovascular disease, and
disabilities due to degenerative joint disease, all related to obesity, marches on.

A final note of advice to investors in the medical field. I would spend my money on a psychiatrist
before investing money in companies conducting research on weight loss medication, since you
won’t see a penny from your investment for ten plus years.

Gary Pepper, M.D.
Editor-in-Chief, Metabolism.com

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