This newly formed trial medication is offering hope for the obese and is showing little side effects.
Arena Pharmaceuticals has its hopes held high with its new product Lorcaserin, currently a trial medication for weight loss, It is starting to make people notice not only with its efficacy with now news out that it has a marketing partner for it. Lorcaserin works deep within the human brain altering various receptors that are linked with controlling ones appetite, as a result this is causing people to want to eat less and therefore they are losing weight. For those who remember the old Fen-Phen (Fenfluramine/Phentermine) combination, Lorcaserin is said to work similarly to how the Fenfluramine functioned however, none of the studies it has been involved in have shown the destructive heart properties that Fenfluramine did. These have been issues studied well because of some initial concern regarding its structural similarity.
Throughout Lorcaserin’s clinical testing it has not only proven to be valuable as a weight loss aid, but gratefully has also shown not only very low side effects but also very low chance of abuse. After years of study and research, Arena Pharmaceuticals has conclusively decided that it was ready to submit it to the FDA in hopes of having it approved as a weight loss drug. This happened December 22nd, 2009. They are now playing the waiting game as they are not expected to hear back from them until October of 2010. But there is a good chance they will find out its destiny in September before an FDA review board. This board will give its input and suggestions on whether they believe the product would be satisfactory to the FDA. From here the FDA takes their recommendations and accordingly decides.
Both Phase 2 and Phase 3 studies have proven Lorcaserin to be effective and seemingly safe. Not only did Lorcaserin successfully surpass the FDA standard for an obesity drug in regards to weight loss, but the side effects reported appeared to be very low and tolerable by the vast majority. Almost half of the patients in trials lost at least 5% of their body weight and almost a quarter lost at least 10%. With regards to side effects, the only side effect reported that was over the 5% difference compared to the placebo was headaches. This looks very favorable in the argument for Lorcaserin given the amount of diet medications producing unwanted side effects.
There are however 3 FDA pending prescription diet pills all in the running at this time. This being said, all three could be passed, or 1 or 2 of them or they all could be rejected. It is too uncertain about the likelihood of each one. The names of the other medications currently in limbo are Qnexa (a unique combination of phentermine and topiramate) and Contrave (a unique combination of naltrexone and bupropion). While these other medications are producing better weight loss in their trials, they also have reported greater side effects. The FDA will look at all three individually in determining their acceptance or refusal.
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