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GW Pharmaceuticals and U.S. Subsidiary Greenwich Biosciences to Present Data on EPIDIOLEX® (cannabidiol) Oral Solution at the American Epilepsy Society Annual MeetingLONDON and CARLSBAD, Calif., Dec. 05, 2019 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq: GWPH), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, along with U.S. subsidiary Greenwich Biosciences announced today that a variety of data, including results from completed Phase 3 trials of EPIDIOLEX® (cannabidiol) oral solution CV, will be presented at the American Epilepsy Society (AES) Annual Meeting, December 6-10, in Baltimore. EPIDIOLEX is approved in the U.S. for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome. It is also approved in Europe, in conjunction with clobazam, for seizures associated with both conditions under the brand name EPIDYOLEX. It is available by prescription for patients two years of age and older. New data from the Phase 3 study of EPIDIOLEX in patients with tuberous sclerosis complex (TSC) will be presented for the first time at the meeting, along with 3-year safety and efficacy results from an open-label extension study in patients with LGS and Dravet syndrome. GW/Greenwich will host commercial and medical booths as well as a scientific exhibit where AES attendees can learn more about EPIDIOLEX. The Company will also host an Innovation Pavilion where attendees can discover the stories of those treated with EPIDIOLEX; hear about the journey of the only CBD product approved by the FDA; and attend an interactive expert-panel discussion on managing patients on EPIDIOLEX. Attendees can also immerse themselves in the Company’s CBD growing and manufacturing processes through an award-winning virtual reality experience. “We are excited to share our latest data for EPIDIOLEX at AES. This is the first time Phase 3 results in TSC will be presented to the epilepsy medical community, along with updated long-term safety and efficacy results in LGS and Dravet syndrome,” said Justin Gover, GW’s Chief Executive Officer. “This has been an exciting first year, with over 15,000 patients treated with EPIDIOLEX, the only FDA-approved cannabidiol (CBD) and the first in a new class of antiepileptic drugs. Our goal is to expand the EPIDIOLEX product label in 2020 to include seizures associated with TSC. Given that the majority of these patients have treatment-resistant epilepsy, we believe there is a need for promising new treatment options.” Meeting activities include: EPIDIOLEX (Booth #517) Innovation Pavilion: Growing Together (Pavilion D)
Scientific Exhibition (Convention Center: Room 324-326, Level 300) Data Presentations Phase 3 and Long-term EPIDIOLEX data
Drug-drug interactions
About EPIDIOLEX® (cannabidiol) oral solution CV EPIDIOLEX, the first prescription, plant-derived cannabinoid medicine in the United States and the first in a new class of anti-epileptic medications, is a pharmaceutical formulation of highly purified cannabidiol (CBD) now FDA approved for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. EPIDYOLEX® (European brand name) is approved in Europe for use as an adjunctive therapy for seizures associated with LGS or Dravet syndrome, in conjunction with clobazam, for patients two years of age and older. GW has received Orphan Drug Designation from the FDA, for EPIDIOLEX for the treatment of Dravet syndrome, LGS and TSC, each of which are severe childhood-onset, drug-resistant syndromes. GW has also received Orphan Designation from the European Medicines Agency, or EMA, for Epidyolex for the treatment of seizures associated with LGS, Dravet syndrome and TSC. About GW Pharmaceuticals plc and Greenwich Biosciences, Inc. Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW’s lead product, EPIDIOLEX (cannabidiol) oral solution CV, is commercialized in the US by its U.S. subsidiary Greenwich Biosciences for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. This product has received approval in Europe under the tradename EPIDYOLEX®. The Company continues to evaluate EPIDIOLEX in additional rare conditions including tuberous sclerosis complex (TSC) and Rett syndrome. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex® (nabiximols), which is approved for the treatment of spasticity due to multiple sclerosis in numerous countries outside the United States and for which the Company is now advancing a late-stage program in order to seek FDA approval. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for epilepsy, autism, glioblastoma, and schizophrenia. For further information, please visit www.gwpharm.com. Important Safety Information Forward-looking statements Enquiries:
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