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Diet Pill Information
June 27th, 2012 News Update:
Lorcaserin has been approved to treat obesity. Its trademarked name will be Belviq®
Buy Lorcaserin / Belviq
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 (Contrave®) 26% - Placebo 13%
Phentermine IR/Topiramate CR (Qnexa®) 18% - Placebo 9%
Orlistat (Xenical® or Alli®) 7% - Placebo 4%
Sibutramine (Meridia®) 9% - Placebo 9%
Rimonabant (Acomplia®) 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.
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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.
Sept 14th, 2010
The FDA said today that Lorcaserin produces minimal weight loss and they are concerned about possible heart damage, depression and other issues. The agency said the average weight loss was about 3% greater than the placebo but does meet at least one of the criteria for the FDA's effectiveness standard "by a slim margin." But these initial findings do not necessarily accurately predict Thursday Sept 16ths Advisory meeting vote.
Sept 16th, 2010
FDA panel voted 9-5 against recommending approval of Arena's lorcaserin. The FDA panel's vote revolves around unanswered safety issues including the development of cancer in lab rats when they where subjected to extremely high dosages. Yet no increase in cancer in humans was reported at regular dosing. The FDA panel are a group of outside experts that make recommendations to the FDA. The FDA is not required to take the advise of the panel but most often does so. The FDA's actual decision will be made on October 22nd of this year.
October 23rd, 2010
The FDA has rejected Lorcaserin for weight loss, in its present form. The FDA requested additional data. The FDA stated "that in the event evidence cannot be provided to alleviate concern regarding clinical relevance of the tumor findings in rats, additional clinical studies may be required to obtain a more robust assessment of lorcaserin's benefit-risk profile." Arena CEO and President Jack Lief stated:
"We intend to meet with the FDA to obtain further clarity on the approval path and timeline. We will work with the agency to address the issues with our NDA as quickly as possible."
November 9th, 2010
Arena released information on its Phase 3 BLOOM-DM trial of Lorcaserin in overweight people also suffering from diabetes. The placebo adjusted weight loss showed a 3% difference. CEO Jack Lief stated that lorcaserin reduced HbA1c levels by 0.9 percent compared to 0.4 percent for placebo (p < 0.0001), with half of the lorcaserin patients getting their HbA1c level below the recommended 7 percent goal, compared to only one-quarter of placebo patients. Another issue is that of valvulopathy, in 2.9% of patients in the trial had it detected compared to 0.5% of the placebo group at week 52 of the study. Arena does not seem to be concerned about it due to such small numbers. They hope to meet and discuss these issues with the FDA before the end of the year and Arena is also interested in trying to gain approval for Lorcaserin in Europe.
December 22nd, 2010
Arena Pharmaceuticals plans to re-submit Lorcaserin to the FDA by the end of 2011. There is even some hope that they may be able to resubmit it sooner as they continue to talk with the FDA. Arena Chief Executive Jack Lief stated "We are encouraged by the outcome of the end-of-review meeting," and "We have additional clarity on next steps as we seek to obtain the FDA's approval of lorcaserin. We're confident we have a path forward."
Clinical Testing will be ongoing particularly regarding tumors found in rats at very high doses.
August 2nd, 2011
Some positive news was released today regarding the issue of tumor concerns with lorcaserin. Studies have shown that the drug appears to accumulate at a much lesser rate in humans than what it does in lab rats. Nine patients who received a standard amount of Lorcaserin for a week had approximately 1.7 times the amount measured in their blood was reaching their brain. Where as lab rats reported 24 times the amount where reaching their brains even with amounts not triggering brain tumors.
November 9th, 2011
In Arena Pharmaceuticals 3rd Quarter Financial Results that where released today, Jack Lief, Arena's CEO and President was quoted as saying "We are focused on submitting our response to the FDA for the lorcaserin complete response letter around year-end and filing the lorcaserin marketing authorization application with the European Medicines Agency in the first half of next year,"
January 3rd, 2012
Arena Pharmaceuticals submitted an authorized response to the FDA that has addressed safety concerns for its obesity fighting drug Lorcaserin. It is believed that the information contained within the letter alleviates the FDA's apprehension about the cancerous tumors that where found in test rats that where believed to have a correlation with Lorcaserin. As always the FDA may not view the found results the same way that Arena or Eisai (makers/promoters) would like them to. It is believed that an official acceptance from the FDA will be announced later this month with a new date announced for an approval decision.
January 10th, 2012
Today it was announced that the FDA has accepted the NDA (new drug application) resubmission for Lorcaserin. As a result, the FDA has provided a target date of June 27th, 2012 where the FDA will make a decision on its approval. This is the Target Action Date.
February 1st, 2012
Further news released from Arena and Eisai Inc today says that the FDA will discuss the Lorcaserin New Drug Application sometime in the 2nd quarter of 2012.
March 2nd, 2012
Arena Pharmaceuticals, Inc declare today they have filed Lorcaserin with the EMA, European Medicines Agency for the treatment of obesity in European Union member countries. It is expected that later this month the EMA will accept the filing to allow for a complete review.
March 26th, 2012
The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for lorcaserin for the treatment of obesity. The FDA has also given a May 10th, 2012 date for the advisory panel, Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss the New Drug Application (NDA).
May 10th, 2012
An advisory panel to the FDA advised that Lorcaserin be approved by a 18-4 vote. It was thought that the benefits outweigh any possible risks. While the FDA usually follows the advice of their panel's vote, it is not bound to do so. The FDA's ultimate decision is expected June 27th, 2012.