{"id":32887,"date":"2013-05-17T11:50:20","date_gmt":"2013-05-17T15:50:20","guid":{"rendered":"http:\/\/asweetlife.org\/?post_type=news&#038;p=32887"},"modified":"2015-12-30T05:09:57","modified_gmt":"2015-12-30T10:09:57","slug":"fda-clears-orameds-oral-insulin-for-trial","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=32887","title":{"rendered":"FDA Clears Oramed&#8217;s Oral Insulin for Trial"},"content":{"rendered":"<p style=\"text-align: justify;\"><a href=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2013\/05\/Oramed-logo.jpg\" rel=\"mfp\"><img decoding=\"async\" class=\"alignleft size-full wp-image-32888 lazyload\" title=\"Oramed logo\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2013\/05\/Oramed-logo.jpg\" alt=\"\" width=\"250\" height=\"125\" \/><\/a>Oramed Pharmaceuticals Inc., a developer of oral drug delivery systems, <a href=\"http:\/\/m.yahoo.com\/w\/legobpengine\/finance\/news\/oramed-receives-fda-clearance-initiate-115000079.html?.intl=us&amp;.lang=en-us\" target=\"_blank\">announced<\/a> today that the United States Food and Drug Administration (FDA) has cleared the Company&#8217;s Investigational New Drug application(IND) for ORMD-0801, its oral insulin capsule.<\/p>\n<p style=\"text-align: justify;\" dir=\"LTR\">Oramed was founded by a group of scientists from Jerusalem\u2019s Hadassah Ein Kerem Medical Center.\u00a0\u00a0<a href=\"http:\/\/oramed.com\/index.php?page=7&amp;fltr=1&amp;item=2\" target=\"_blank\">Dr. Miriam Kidron<\/a>, who was part of that team, had been working for over twenty-five years on the development of oral insulin.\u00a0 In 2006, the team had a breakthrough when they figured out how to correctly work the technology that would enable oral insulin to be effective. At that time,\u00a0<a href=\"http:\/\/oramed.com\/index.php?page=7&amp;fltr=1&amp;item=1\" target=\"_blank\">Nadav Kidron<\/a>, the son of Miriam Kidron, decided it was time to bring this product to the market. Together with his mother, he founded Oramed. \u00a0\u201dWhen the technological basis seemed sound, I readily enlisted myself to help leverage the years of research toward commercializing this concept as soon as possible,\u201d said Nadav.<\/p>\n<p style=\"text-align: justify;\" dir=\"LTR\">The development of oral insulin has been no simple task.\u00a0 \u201cPeople have been dreaming about oral insulin since 1922,\u201d Dr. Kidron said.\u00a0 Because insulin is a protein, it\u2019s easily broken down by enzymes in the digestive tract, just like any protein we eat.\u00a0 An unprotected insulin tablet has no chance to do its job in the harsh environment of the gut.\u00a0 And furthermore, insulin is a very large molecule, meaning it can\u2019t be easily absorbed through the gut wall and circulated to the tissues where it is needed.<\/p>\n<p style=\"text-align: justify;\" dir=\"LTR\">To combat these problems, Oramed has come up with a platform technology which can work not only with insulin, but with other peptides, like GLP-1 analogues (Byetta and\u00a0<a href=\"https:\/\/asweetlife.org\/a-sweet-life-staff\/featured\/victoza-on-the-rise-paula-deen-promotes-type-2-diabetes-drug\/23843\/\" target=\"_blank\">Victoza<\/a>\u00a0are two current GLP-1 analog drugs on the market.)\u00a0 Oramed\u2019s technology provides protection against natural obstacles within the gastrointestinal tract, without jeopardizing the drug integrity and bioavailability.\u00a0 The formulation involves a simple blend of insulin with protective reagents, provided at precisely calibrated concentrations and ratios.\u00a0 Oramed\u2019s drugs do not require any modification of active ingredients, so they can be administered in their natural state.\u00a0 Because the technology doesn\u2019t require changing the insulin molecule, the pre-marketing regulatory processes is shorter.<\/p>\n<p style=\"text-align: justify;\">&#8220;We are very pleased to have the FDA clearance to proceed,&#8221; stated\u00a0Nadav Kidron, CEO of Oramed. &#8220;The upcoming trial is a major milestone for Oramed and we look forward to continuing to progress ORMD-0801&#8217;s clinical development in the U.S.&#8221;<\/p>\n<p style=\"text-align: justify;\">For more on Oramed see <a href=\"https:\/\/asweetlife.org\/feature\/insulin-in-a-capsule-the-promising-development-of-oral-insulin\/\" target=\"_blank\">here<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&hellip;<\/p>\n","protected":false},"author":131,"featured_media":32888,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1441],"tags":[311],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.9 (Yoast SEO v22.9) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA Clears Oramed&#039;s Oral Insulin for Trial<\/title>\n<meta name=\"description\" content=\"Oramed announced today that the US FDA has 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