This is a follow up to a post earlier this week that mentioned the standards that obesity drug makers had to meet for FDA approval of their drug.
There are three drugs that are showing promise these days. They are all in late stage trials and so have proved safety, minimal side effects and efficacy. They now have to meet the FDA standard of at least 5% weight loss in a third of the study group and a doubling in the number of weight loss experiment “losers” compared to the placebo group.
Recently Arena Pharmaceuticals had noted some success and were due to release results of their most recent trial, today. Yesterday there was a lot of buying of the company’s stock, ahead of the report.
I tell you this because obesity is big business and investors go nuts over the thought of owning shares of that true block buster drug.
It is said that the results related to lorcaserin were not as significant as hoped and some shares were promptly sold this morning. The problem being that the placebo group also lost weight with a comparison of 6.5% body weight lost in subjects to 3.9% in placebo. Perhaps too close to get FDA approval.
What I found interesting in the Miami Herald article I read was this statement, “a program of moderate diet and exercise is standard for all patients in late-stage studies of obesity drugs.” REALLY? Why will a person participate in this safe and effective weight loss “concept” in a drug trial but not in real life?
The other two drugs that are vying for market share and FDA approval are Contrave and Qnexa. Where do these names come from?
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