Friday, September 17, 2010

Lorcaserin Failed to Get FDA Advisory Panel Recommendation

Ipsos Vantis, a pharmaceutical market researcher, estimates that "between one-half and two-thirds of primary care physicians would likely prescribe" any one of the three weight loss drugs currently in the pipeline. The three drugs are qnexa, manufactured by Vivus, lorcaserin produced by Arena, and contrave manufactured by Orexigen. However, as we reported recently, an FDA advisory panel rejected qnexa. And on Thursday of this week, an FDA panel failed to recommend lorcaserin.

One concern the panel had was whether persons taking lorcaserin might be "more likely to develop valvular heart disease." Lorcaserin suppresses the appetite in a way similar to the way the drug fenfluramine suppresses the appetite. And the FDA requested that fenfluramine be taken off the market in the 90s.

The drug was the "fen" part of the combination weight loss drug, fen-phen, which caused severe side effects in patients. However, even though lorcaserin has some things in common with fenfluramine, lorcaserin is said to have fewer and less severe side effects than fenfluramine.

The "phen" part of fen-phen was phentermine. Phentermine is one of the two drugs that comprises Qnexa, another weight loss drug an FDA panel recently rejected. And phentermine is still being prescribed for weight loss and weight management.

Although Qnexa was effective in weight loss, the panel had concerns about the drug when taken in high doses. And participants in qnexa-usage studies experienced thoughts of suicide, anxiety, palpitations, and problems concentrating.

If the FDA does eventually decide to approve lorcaserin or qnexa or contrave, it will be welcomed by the weight loss market. According to Ipsos Vantis, 'U.S. retail sales for any of these three drugs [could] exceed $400 million on an annual basis within 3-5 years of launch.'

And Indeed, if one of the three weight loss drugs gains FDA approval, the use of the drug in combination with exercise, diet, and counseling, could lead to long term weight loss for many patients. And this would be a good thing for both patients and medical weight loss practitioners.

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