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当前位置:药品说明书与价格首页 >> 综合药讯 >> 新型特效减肥药—Lorcaserin Hydrochloride获得FDA的批准即将上市

新型特效减肥药—Lorcaserin Hydrochloride获得FDA的批准即将上市

2010-07-24 16:52:42  作者:新特药房  来源:中国新特药网天津分站  浏览次数:598  文字大小:【】【】【
简介: 一种在研的新型减肥药Lorcaserin一年以后即将问世,与别的减肥药不同,它不会导致心脏问题,很多希望减少体重并保持减肥效果的人很快就能够圆梦。 这种减肥药由Arena制药公司出品,是三种效果更理想的 ...

一种在研的新型减肥药Lorcaserin一年以后即将问世,与别的减肥药不同,它不会导致心脏问题,很多希望减少体重并保持减肥效果的人很快就能够圆梦。

这种减肥药由Arena制药公司出品,是三种效果更理想的新一代减肥药之一。其中一种在本周四将开始接受FDA的审查,另外两种将在今年后期接受审查。

临床实验结果显示,受试者使用Lorcaserin进行为期一年的治疗之后,更多的人能减轻原来体重的5%,达到这一减肥效果的人数比例是其他药物的两倍多。

而且除了头痛和头晕,Lorcaserin在其他不良反应方面的情况与安慰剂差不多。人们最关心的一点——心脏瓣膜问题也没有出现,但如果要完全证明这一点则需要进行更大规模的实验。而且与别的减肥药不同,患者用了这种药以后心率和血压并未升高,事实上,他们用药后体内胆固醇水平和其他与心脏病先关的风险因素反而得到改善。

通常情况下,需要减肥的人很难坚持饮食方面的控制。而通过作用于饮食起效的减肥药要么有严重的副作用,要么不能长期使用。1997年著名减肥药“芬芬”因导致心脏瓣膜方面的不良反应而撤出市场,这让这类药物跌入了低谷。

但随着Lorcaserin的出现,这种蓝色圆形片剂一旦最终获准,它将可能成为十多年来首个真正具有上佳减肥效果的新型药物。它跟“芬芬”一样,通过抑制食欲起作用,但它的靶向部位挑选得更为精细,使用起来也会更为安全。
Lorcaserin is a promisingnewdietpillbeingmanufactured 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 cardiacfibrosis,Lorcaserinworksmoreselectively 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 ultimatelyknownuntilthetentative 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% - Placebo13PhentermineIR/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.

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 inSwitzerland 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.

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