FDA rejects another obesity drug, raising questions about market niche

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In theory, pharmaceutical companies have billions of reasons to develop and market an obesity drug, given the epidemic weight problem in the U.S.

The reality, however, is that sales of existing drugs have been modest, in part because the drugs don’t produce dramatic results on their own.  Weight losses of 1 percent to 3 percent of body weight over a year aren’t a big help for severely obese patients, and that’s all they can do in most cases.

Adding insult to injury, the FDA  has rejected yet a third obesity drug this week, adding another barrier to raking in the profits from treating overweight Americans.

The rejected drug, Qnexa combined already-approved stimulant phentermine and topiramate (Topamax), which is used to treat epilepsy and migraines. It was turned down by the agency over safety concerns.

The rejection comes in the wake of two other actions against makers of obesity drugs. Last week, the FDA declined to approve new drug lorcaserin because it caused rat tumors.  Earlier in October, meanwhile, the agency forced the withdrawal of Meridia from the market after 13 years, citing heart attack and stroke risks for some patients. That leaves only Roche’s Xenical available as an approved long-term weight management drug.

All may not be lost for Qnexa. Drugmaker Vivus, which is now responding to an FDA request for an evaluation of its potential for causing birth defects and heart problems, has said it can address the agency’s concerns within six weeks or so.  If it succeeds in calming the agency’s fears, it could yet get the drug approved, according to The New York Times.

But the bigger picture for these drugs is hazier at best. The FDA seems inclined to approve only drugs which aren’t prone to overuse — or in other words, which don’t work that well — as one expert told the Times.  And markets aren’t build on mediocre products which don’t excite buyers or sell too well, are they folks?

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Greg November 5, 2010 at 2:55 pm

The FDA would never approve a drug that succeeds in killing appetite. Too many executives in the food industry would suffer a loss, and the lobbyists they send to the FDA would not like that.


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