{"id":7831,"date":"2017-11-04T01:22:59","date_gmt":"2017-11-04T01:22:59","guid":{"rendered":"http:\/\/www.denverpost.com?p=2845536&amp;preview_id=2845536"},"modified":"2017-11-04T01:22:59","modified_gmt":"2017-11-04T01:22:59","slug":"a-significant-event-cbd-based-pharmaceutical-drug-epidiolex-presented-to-fda-for-approval","status":"publish","type":"post","link":"https:\/\/cannitrol.com\/blog\/a-significant-event-cbd-based-pharmaceutical-drug-epidiolex-presented-to-fda-for-approval\/","title":{"rendered":"\u201cA significant event\u201d: CBD-based pharmaceutical drug Epidiolex presented to FDA for approval"},"content":{"rendered":"<div id=\"wp_fb_like_button\" style=\"margin:5px 0 5px 5px;float:right;height:100px;\"><script src=\"http:\/\/connect.facebook.net\/en_US\/all.js#xfbml=1\"><\/script><fb:like href=\"https:\/\/cannitrol.com\/blog\/a-significant-event-cbd-based-pharmaceutical-drug-epidiolex-presented-to-fda-for-approval\/\" send=\"true\" layout=\"standard\" width=\"450\" show_faces=\"false\" font=\"arial\" action=\"like\" colorscheme=\"light\"><\/fb:like><\/div><div class=\"media_block\"><\/div>\n<div class=\"row\">\n<div class=\"large-10 large-centered small-12 columns\">\n<div class=\"entry-meta-date\">Published: Nov 3, 2017, 4:49 pm \u2022 Updated: Nov 3, 2017, 4:56 pm<span class=\"single-comments-link\" \/><\/div>\n<p class=\"byline\">By <span class=\"author\"><a class=\"url fn n\" href=\"http:\/\/www.thecannabist.co\/author\/awallace\/\" rel=\"author\">Alicia Wallace<\/a><\/span><em>, The Cannabist Staff<\/em><\/p>\n<p>A CBD-based pharmaceutical drug in development is one more step closer to potential FDA approval.<\/p>\n<p>Earlier this week, London-based GW Pharmaceuticals plc, which operates in the United States as Greenwich Biosciences, wrapped up its <a href=\"http:\/\/www.thecannabist.co\/2017\/10\/06\/cbd-epidiolex-gw-pharmaceuticals-fda-hemp-industry\/89387\/\">New Drug Application for Epidiolex<\/a>, a formulation of the cannabis compound cannabidiol (CBD) for the treatment of seizures associated with two specific types of epilepsy: <a href=\"http:\/\/www.thecannabist.co\/2014\/12\/05\/special-report-cbd-oil-colorado\/24772\/\">Lennox-Gastaut syndrome and Dravet syndrome<\/a>.<\/p>\n<p>\u201cThe submission is a significant event,\u201d said Steve Schultz, a GW spokesman.<\/p>\n<figure class=\"figure wp-caption aligncenter\"><img loading=\"lazy\" src=\"https:\/\/cannitrol.com\/blog\/\/wp-content\/uploads\/2017\/11\/a-significant-event-cbd-based-pharmaceutical-drug-epidiolex-presented-to-fda-for-approval.jpg\" alt=\"cbd oil epilepsy\" width=\"1000\" height=\"620\" class=\"size-full wp-image-80261\" \/><figcaption class=\"wp-caption-text\">GW Pharmaceuticals\u2019 Epidiolex, a medicine made from cannabis containing cannabidiol (CBD), is shown in New York. (Kathy Young, Associated Press)<\/figcaption><\/figure>\n<p>The Epidiolex submission file was \u201cthousands of documents\u201d thick, encompassing data and details spanning the areas such as preclinical, clinical, manufacturing and distribution, he said. The submission includes clinical data on 1,500 patients, 400 of whom have had <a href=\"http:\/\/www.thecannabist.co\/2016\/12\/30\/marijuana-research-of-2016\/69971\/\">more than a year of exposure to Epidiolex<\/a>.<\/p>\n<p>\u201cFor an orphan drug, that is a very significant set of facts,\u201d he said. \u201cFor any pharmaceutical company, it\u2019s a major achievement.\u201d<\/p>\n<p>Now Epidiolex\u2019s fate is <a href=\"http:\/\/www.thecannabist.co\/tag\/food-and-drug-administration\/\">in the hands of the U.S. Food and Drug Administration<\/a>, which is expected to respond within 60 days from the Oct. 30 submission.<\/p>\n<p>If the FDA gives the OK, facilities inspections, additional reviews and a potential rescheduling for Epidiolex could occur during the following months, Schultz said. If all goes smoothly, Epidiolex could be on the market by this time next year.<\/p>\n<p>It\u2019s been a busy week for federal oversight of CBD. On Oct. 31, <a href=\"http:\/\/www.thecannabist.co\/2017\/11\/01\/fda-warning-letters-cbd-health-claims-cw-hemp\/91378\/\">The FDA issued warning letters<\/a> to four companies that make hemp-derived CBD products for illegally making unsubstantiated health claims about the cannabis compound in treating conditions such as cancer.<\/p>\n<p>When asked if the timing of GW\u2019s NDA submission and the subsequent warning letters were connected, FDA spokesman Michael Felberbaum said Friday he could not comment on the pending NDA. In correspondence with The Cannabist earlier this week, Felberbaum said the agency had issued similar warning letters in <a href=\"https:\/\/www.fda.gov\/NewsEvents\/PublicHealthFocus\/ucm484109.htm\">2015 and 2016<\/a>.<\/p>\n<p>GW is expecting \u201csignificant demand\u201d from the <a href=\"http:\/\/www.thecannabist.co\/2017\/06\/19\/cbd-oil-epilepsy-child-fda\/80781\/\">Lennox-Gastaut and Dravet patient populations<\/a>, which total close to 35,000 patients and 8,000 patients, respectively.<\/p>\n<p>The company is running additional trials to assess how Epidiolex could fare in treating other conditions, such as infantile spasms, but there is \u201can unknown upside \u2026 of this sphere of influence\u201d with Epidiolex, Schultz said. GW would not promote Epidiolex for any conditions beyond what it submitted for approval on the label \u2014 Lennox-Gastaut and Dravet.<\/p>\n<p>\u201cIt will be up to the physician and the patient to determine what the best therapeutic options are,\u201d he said. \u201cBetween the patient, physician and payor.\u201d<\/p>\n<p>Analysts have estimated that Epidiolex could be a $1 billion drug for GW Pharmaceuticals. Analysts also are closely watching for the latest results from clinical trials.<\/p>\n<p>\u201cWe expect investors will shift their focus to upcoming data presentations expected at the American Epilepsy Society (AES) annual meeting being held Dec. 1-5 in Washington, D.C.,\u201d Andrew S. Berens, a Morgan Stanley analyst, wrote in a research note published Oct. 30. \u201cWe expect focus will specifically be on anticipated drug-drug interaction (DDI) data expected at the meeting, as management anticipates presenting pooled data from the two Phase 3 LGS trials showing response rates at different thresholds and in the subgroups of patients with or without concomitant Onfi (clobazam).\u201d<\/p>\n<figure class=\"figure wp-caption alignleft\"><img loading=\"lazy\" src=\"https:\/\/cannitrol.com\/blog\/\/wp-content\/uploads\/2017\/11\/a-significant-event-cbd-based-pharmaceutical-drug-epidiolex-presented-to-fda-for-approval-1.jpg\" alt=\"hemp-festival-colorado-marijuana-events-march-2016\" width=\"500\" height=\"351\" class=\"size-medium wp-image-49386\" \/><figcaption class=\"wp-caption-text\">Mature hemp plants are examined at the CBDRx Natural Healing organic hemp farm in Longmont, Colorado, in October 2015. (RJ Sangosti, Denver Post file)<br \/><\/figcaption><\/figure>\n<p>Clobazam is the generic name for <a href=\"https:\/\/www.epilepsy.com\/medications\/clobazam\">a drug approved for add-on treatment of seizures<\/a> in children age 2 and older and adults who have seizures associated with Lennox-Gastaut. It is sold in the U.S. under the brand name Onfi.<\/p>\n<p>There is concern about clobazam\u2019s role in the effectiveness of Epidolex, Ken Trbovich, an analyst with Janney Montgomery Scott, <a href=\"http:\/\/www.thecannabist.co\/2017\/10\/06\/cbd-epidiolex-gw-pharmaceuticals-fda-hemp-industry\/89387\/\">previously told The Cannabist<\/a>. Another concern for GW included the existing prevalence of hemp-derived CBD extracts currently on the market, he said.<\/p>\n<p>On the other hand, companies within the cottage CBD extract industry <a href=\"http:\/\/www.thecannabist.co\/2017\/10\/06\/cbd-epidiolex-gw-pharmaceuticals-fda-hemp-industry\/89387\/\">have expressed wariness<\/a> about GW\u2019s progress and what the <a href=\"http:\/\/www.thecannabist.co\/2017\/03\/03\/south-dakota-cbd-oil-fda-approval\/74832\/\">emergence of an FDA-approved<\/a> formulation of CBD could mean for their livelihoods.<\/p>\n<p>GW\u2019s Schultz previously has stated that Epidiolex will be an \u201cadditional option\u201d in the market. He reiterated those statements this week.<\/p>\n<p>\u201cOur goal is to provide an additional option,\u201d he said. \u201cWe know that physicians and patients and parents of young patients desire to have a pharmaceutical medicine for the treatment of these seizures, especially these really challenging seizures.\u201d<\/p>\n<hr \/>\n<h4>Cannabist 2017 Special Report: CBD, TBD<\/h4>\n<p><strong>Part I \u2013 <a href=\"http:\/\/www.thecannabist.co\/2017\/06\/20\/cbd-medical-marijuana-new-york-cannabidiol-cbd-oil\/81926\/\">Forbidden medicine: Caught between a doctor\u2019s CBD advice and federal laws<\/a><\/strong><\/p>\n<p><strong>Part II \u2013 <a href=\"http:\/\/www.thecannabist.co\/2017\/06\/26\/cbd-oil-medical-marijuana-federal-charlottes-web\/82258\/\">How advocates are inspiring congressional action on CBD legalization<\/a><\/strong><\/p>\n<p><strong>Part III \u2013 <a href=\"http:\/\/www.thecannabist.co\/2017\/07\/05\/cbd-hemp-dea-marijuana-extracts-federal-lawsuit\/82623\/\">With DEA digging in its heels on \u201cmarijuana extracts,\u201d legality of CBD oil on trial in federal courts<\/a><\/strong><\/p>\n<p><strong>Part IV \u2013 <a href=\"http:\/\/www.thecannabist.co\/2017\/07\/12\/cbd-pet-products-dogs-cannabidiol-research\/83474\/\">CBD research is going to the dogs in quest to legitimize pet products<\/a><\/strong><\/p>\n<p><strong>Part V \u2013 <a href=\"http:\/\/www.thecannabist.co\/2017\/09\/20\/cbd-international-law-who-fda-cannabis\/88429\/\">CBD on the international stage: WHO committee delving into science, control status of cannabis compound<\/a><\/strong><\/p>\n<p><strong>Part VI \u2013 <a href=\"http:\/\/www.thecannabist.co\/2017\/10\/06\/cbd-epidiolex-gw-pharmaceuticals-fda-hemp-industry\/89387\/\">Race for CBD medication breakthrough: Is pharma firm\u2019s boon the hemp industry\u2019s doom?<\/a><\/strong><\/p>\n<div class=\"entry-meta-tags\">\n<div class=\"entry-tags\">Topics: <a href=\"http:\/\/www.thecannabist.co\/tag\/cannabidiol\/\" rel=\"tag\">cannabidiol<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/cbd\/\" rel=\"tag\">cbd<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/childhood-epilepsy\/\" rel=\"tag\">childhood epilepsy<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/clinical-trials\/\" rel=\"tag\">clinical trials<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/epidiolex\/\" rel=\"tag\">Epidiolex<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/epilepsy\/\" rel=\"tag\">epilepsy<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/food-and-drug-administration\/\" rel=\"tag\">Food and Drug Administration<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/gw-pharmaceuticals\/\" rel=\"tag\">gw pharmaceuticals<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/hemp\/\" rel=\"tag\">hemp<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/prescription-drugs\/\" rel=\"tag\">prescription drugs<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/research\/\" rel=\"tag\">research<\/a><\/div>\n<\/div>\n<div class=\"entry-meta-author\">\n<div class=\"authorimage\"><a class=\"url fn n\" href=\"http:\/\/www.thecannabist.co\/author\/awallace\/\" rel=\"author\"><img src=\"https:\/\/cannitrol.com\/blog\/\/wp-content\/uploads\/2017\/11\/a-significant-event-cbd-based-pharmaceutical-drug-epidiolex-presented-to-fda-for-approval-2.jpg\" class=\"authormug\" \/><\/a><\/div>\n<p class=\"author-desc\">Alicia Wallace joined The Cannabist in July 2016, covering national marijuana policy and business. In her 14 years as a business news reporter, her coverage has spanned topics such as the economy, natural foods, airlines, biotech, retail,&#8230;<\/p>\n<\/div><\/div>\n<\/p><\/div>\n<p><!-- .row --> <\/p>\n","protected":false},"excerpt":{"rendered":"<div class=\"media_block\"><\/div>\n<p>GW Pharmaceuticals, a.k.a. Greenwich Biosciences, has submitted to the FDA a New Drug Application for Epidiolex, a cannabis-based epilepsy drug with CBD. <\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[5062,531,330,7153,55,6813,77,5667,9,6833,5019,1357,1777,1,3,61,1736],"tags":[5063,3105,2908,7155,2635,6818,2655,5673,6835,5022,3927,4345],"_links":{"self":[{"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/posts\/7831"}],"collection":[{"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/comments?post=7831"}],"version-history":[{"count":0,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/posts\/7831\/revisions"}],"wp:attachment":[{"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/media?parent=7831"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/categories?post=7831"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/tags?post=7831"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}