{"id":9657,"date":"2016-08-12T09:58:21","date_gmt":"2016-08-12T09:58:21","guid":{"rendered":"http:\/\/revoscience.com\/en\/?p=9657"},"modified":"2016-08-12T09:58:21","modified_gmt":"2016-08-12T09:58:21","slug":"fda-approves-heron-therapeutics-chemo-anti-nausea-drug","status":"publish","type":"post","link":"https:\/\/www.revoscience.com\/en\/fda-approves-heron-therapeutics-chemo-anti-nausea-drug\/","title":{"rendered":"FDA Approves Heron Therapeutics Chemo Anti-Nausea Drug"},"content":{"rendered":"<p style=\"text-align: justify;\"><span style=\"color: #000000;\"><a href=\"http:\/\/revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602.jpg\" target=\"_blank\" rel=\"noopener\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-9659\" src=\"http:\/\/revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602.jpg\" alt=\"shutterstock_154905602\" width=\"1280\" height=\"512\" title=\"\" srcset=\"https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602.jpg 1280w, https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602-300x120.jpg 300w, https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602-1024x409.jpg 1024w\" sizes=\"auto, (max-width: 1280px) 100vw, 1280px\" \/><\/a>Heron Therapeutics Inc.\u2019s injectable therapy, Sustol (granisetron), for chemotherapy-induced nausea and vomiting (CINV)\u00a0<a style=\"color: inherit;\" href=\"http:\/\/www.businesswire.com\/news\/home\/20160810005389\/en\/Heron-Therapeutics-Announces-U.S.-FDA-Approval-SUSTOL%C2%AE\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #000000;\">was approved<\/span><\/a>\u00a0by the U.S. Food and Drug Administration Wednesday, August 11.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #000000;\">Sustol is the first approved product that uses Heron\u2019s Biochronomer drug-delivery technology, which maintained effective levels of the medication for at least five days, covering the acute and delayed phases of CINV. A global, Phase 3 program, composed of two, large clinical trials, evaluated Sustol\u2019s efficacy and safety in more than 2,000 patients with cancer.<\/span><\/p>\n<p style=\"text-align: justify;\">[pullquote]\u201cDespite advances in the management of CINV, up to half of patients receiving chemotherapy can still experience CINV, with delayed CINV being particularly challenging to control,\u201d said Dr. Ralph Boccia.[\/pullquote]<\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #000000;\">The newly approved drug is a serotonin-3 (5-HT3) receptor antagonist used in combination with other antiemetics.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #000000;\">Sustol had been rejected twice previously by the FDA. In 2010, Heron (then called A.P. Pharma) received its first rejection for Sustol. The company returned with additional data, but three years later, the drug was again rejected due to manufacturing and data analysis problems.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #000000;\">\u201cDespite advances in the management of CINV, up to half of patients receiving chemotherapy can still experience CINV, with delayed CINV being particularly challenging to control,\u201d said Dr. Ralph Boccia, medical director at the Center for Cancer and Blood Disorders, in the release. \u201cIn our experience, other 5-HT3 receptor antagonists, including palonosetron, are generally effective for 48 hours or less.\u201d<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #000000;\">CINV, one of the most acute side effects of chemotherapy, occurs in up to 80 percent of patients and has a significant impact on a patient\u2019s quality of life, according to the\u00a0<a style=\"color: inherit;\" href=\"http:\/\/www.cancer.gov\/about-cancer\/treatment\/side-effects\/nausea\/nausea-hp-pdq\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #000000;\">National Cancer Institute<\/span><\/a>.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sustol is the first approved product that uses Heron\u2019s Biochronomer drug-delivery technology, which maintained effective levels of the medication for at least five days, covering the acute and delayed phases of CINV. A global, Phase 3 program, composed of two, large clinical trials, evaluated Sustol\u2019s efficacy and safety in more than 2,000 patients with cancer.<\/p>\n","protected":false},"author":6,"featured_media":9659,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[26,17],"tags":[],"class_list":["post-9657","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicine","category-research"],"featured_image_urls":{"full":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602.jpg",1280,512,false],"thumbnail":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602-150x150.jpg",150,150,true],"medium":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602-300x120.jpg",300,120,true],"medium_large":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602.jpg",750,300,false],"large":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602-1024x409.jpg",750,300,true],"1536x1536":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602.jpg",1280,512,false],"2048x2048":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602.jpg",1280,512,false],"ultp_layout_landscape_large":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602.jpg",1200,480,false],"ultp_layout_landscape":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602.jpg",870,348,false],"ultp_layout_portrait":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602.jpg",600,240,false],"ultp_layout_square":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602.jpg",600,240,false],"newspaper-x-single-post":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602.jpg",760,304,false],"newspaper-x-recent-post-big":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602.jpg",550,220,false],"newspaper-x-recent-post-list-image":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602.jpg",95,38,false],"web-stories-poster-portrait":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602.jpg",640,256,false],"web-stories-publisher-logo":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602.jpg",96,38,false],"web-stories-thumbnail":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/08\/shutterstock_154905602.jpg",150,60,false]},"author_info":{"info":["Amrita Tuladhar"]},"category_info":"<a href=\"https:\/\/www.revoscience.com\/en\/category\/health\/medicine\/\" rel=\"category tag\">Medicine<\/a> <a href=\"https:\/\/www.revoscience.com\/en\/category\/news\/research\/\" rel=\"category tag\">Research<\/a>","tag_info":"Research","comment_count":"0","_links":{"self":[{"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/posts\/9657","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/comments?post=9657"}],"version-history":[{"count":0,"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/posts\/9657\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/media\/9659"}],"wp:attachment":[{"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/media?parent=9657"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/categories?post=9657"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/tags?post=9657"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}