Lorcaserin Diet Pill

          Lorcaserin is a promising new diet pill being manufactured by Arena Pharmaceuticals, based out of California. Their stock symbol traded on the NASDAQ is ARNA. At the time of this writing Lorcaserin does not have a trademarked name associated with it at this time. It is most likely that if it is passed by the FDA that a trademarked name will be attached to it. Lorcaserin is an appetite suppressant, it essentially adjusts chemicals in the brain and helps to eliminate hunger. More scientifically speaking, it stimulates parts of the 5-HT2C serotonin receptors located in the hypothalamus or control center for metabolism and appetite. For those who remember the dreaded drug Fen-Phen, Lorcaserin has a similar chemical structure as that of the Fen part (Fenfluramine). But unlike Fenfluramine which was discontinued in 1997 due to causing heart valve disease, pulmonary hypertension or cardiac fibrosis, Lorcaserin works more selectively and has NOT shown any of the destructive heart issues that Fenfluramine has.

          Lorcaserin has shown through trial testing that it could be a good candidate for an obesity reducing drug. So much so that Arena Pharmaceuticals submitted it to the FDA in hopes of having it approved. The date they submitted it on was December 22nd 2009. As a result there will be an FDA committee to review their NDA (New Drug Application) September 16th, 2010. From this advisory committee often comes the fate of the drug. The FDA will tentatively meet October 22nd 2010 for its decision on acceptance or not of the drug. The FDA usually takes the advice from the advisory committee on whether to pass it or not but this is not always the case so the final decision will not be ultimately known until the tentative date of October 22nd.
          In early clinical testing with Lorcaserin (Phase 2) Arena showed that patients receiving Lorcaserin lost more weight that those receiving the placebo. Three different amounts where administered over a 12 week period. The amount of Lorcaserin where 10mg/day, 15mg/day and 20mg/day, at the end of the 12 weeks those taking lorcaserin lost an average of 4.0 lbs (10mg dosage), 5.7lbs (15mg dosage) and 7.9lbs (20mg dosage) It was also reported that cholesterol levels improved but blood pressure remained constant. The test group taking the placebo averaged just 0.7lbs decrease during this time. The group members also where not monitored for their diet or exercise during their study. During Phase 3 trials, testing showed that 22% of lorcaserin patients lost at least 10% of their weight compared to the 7.7% of placebo takers and 47.5% of patients taking lorcaserin lost at least 5% of their weight versus the 20.3% for placebo patients. On average Lorcaserin patients lost 5.8% of their weight (12.7lbs) verses 2.2% for placebo takers or 4.7lbs. Comparing this to the FDA standard and Lorcaserin passes, for the FDA standard for a drug to be a weight loss drug, it must have at least 1/3 of the patients lose at least 5% of their weight or that at least two times the patients must lose 5% bodyweight when compared to those taking the placebo.

          Side effects that have been reported where nausea, dry mouth, fatigue, headache, dizziness, vomiting and urinary tract infections. The most common was headache where approximately 18% experienced them verses 11% for the placebo group. Infact headaches where the only side affect that had a rate of 5% above the placebo experience. These side effects where determined to be generally well tolerated. Infact the discontinue rate for patients involved in Lorcaserin studies where about the same (7%) for both users and placebo users. This is the lowest discontinue percentage to any other obesity drug in a phase three trial. Discontinue rates for other obesity drugs in phase three trials where reported to be:

Bupropion SR/Naltrexone IR (ContraveŽ) 26% - Placebo 13%
Phentermine IR/Topiramate CR (QnexaŽ)    18% - Placebo 9%
Orlistat (XenicalŽ or AlliŽ) 7% - Placebo 4%
Sibutramine (MeridiaŽ) 9% - Placebo 9%
Rimonabant (AcompliaŽ) 15% - Placebo 7%

          Further benefits that favor Lorcaserin are that in December of 2009, news was released stating that Lorcaserin has a low abuse potential for addiction or from recreational drug users seeking to get a "high". This could be substantial news in the FDA's eyes come decision time. Lorcaserin has also shown benefits in cardiovascular risk factors.

July 1st, 2010
Arena Pharmaceuticals released news today stating that they have signed a deal with Eisai Co of Japan to sell its obesity drug in the US if it achieves approval. The deal states that Arena will produce its drug at its manufacturing plant located in Switzerland then sell the completed product to Eisai who then will have exclusive marketing rights. Under the agreement Arena will receive $50million dollars upfront and up to an additional $90 million if FDA approved and for the delivery of the product for sale. It is their goal that if approved to start selling Lorcaserin 12 weeks after the approval date. This shot their stock price as high as $3.70 today from a close of $3.07 yesterday.

July 14th, 2010
A study with Lorcaserin has shown that it is effective for weight loss and without heart-related side effects and generally little risk. The study also showed that lorcaserin caused more people to lose at least 5 % of their weight over a one year period, equating more than double the rate of placebo group. The results are in Thursday's New England Journal of Medicine.