{"id":889,"date":"2011-02-25T10:31:24","date_gmt":"2011-02-25T10:31:24","guid":{"rendered":"http:\/\/www.medic8.com\/news\/?p=889"},"modified":"2011-02-25T10:31:24","modified_gmt":"2011-02-25T10:31:24","slug":"fda-wants-more-trials-on-weight-loss-drug-8614","status":"publish","type":"post","link":"https:\/\/www.medic8.com\/news\/fda-wants-more-trials-on-weight-loss-drug-8614\/","title":{"rendered":"FDA Wants More Trials On Weight Loss Drug-8614"},"content":{"rendered":"

The Food and Drug Administration the powerful US Quango that controls the licensing of drugs, has ordered a pharmaceutical company to carry out more trials on a new weight loss<\/a> drug it\u2019s developing.<\/p>\n

Last October, the FDA rejected the drug Lorcaserin basing its decision on a possibility that the compound is a cancer<\/a> risk. The regulator also ordered research to be carried out to assess a potential link between Lorcaserin and the development of mammary tumours in rats. The FDA also wanted the company to see whether use of Lorcaserin increased release of protactin, a natural hormone released by the pituitary gland.<\/p>\n

Despite carrying out these requests the FDA announced last week that they wanted the pharmaceutical company to carry out further trials; these trials must also include a 12 month study involving female rats.<\/p>\n

Unfortunately for the pharmaceutical company, this new directive caused a share drop of some 15%.<\/p>\n

On hearing the news one analyst said: “We believe the new requests add to the regulatory uncertainty and will most likely push out resubmission of the NDA (new drug application) beyond the company’s guidance of end of 2011.\u201d<\/p>\n

The company however disputes this analysis saying that they can resubmit Lorcaserin NDA by the end of this year.<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

The Food and Drug Administration the powerful US Quango that controls the licensing of drugs, has ordered a pharmaceutical company to carry out more trials on a new weight loss drug it\u2019s developing. Last October, the FDA rejected the drug Lorcaserin basing its decision on a possibility that the compound is a cancer risk. The […]<\/p>\n","protected":false},"author":888008809,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[15],"tags":[277,45,149,87],"class_list":["post-889","post","type-post","status-publish","format-standard","hentry","category-weight-loss","tag-cancer-risk","tag-food-and-drugs-administration","tag-lorcaserin","tag-weight-loss-drugs"],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t