Amarin Receives Special Protocol Assessment Treaty From The FDA For Phase 3 Cardiovascular Test
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Amarin Convention plc (NASDAQ:AMRN) announced that it has reached agreement with the U.S. Food and Narcotic Administration (FDA) under a Exceptional Protocol Assessment (SPA) for its deliberate Sheet 3 registration clinical proof of AMR101 (ethyl-EPA) in patients with hypertriglyceridemia, or identical high triglyceride levels. The SPA is a written agreement between the Company, as the trial's sponsor, and the FDA regarding the design, endpoints, and planned statistical conversation of the Stage 3 check to be used in backing of a Dewy Drug Exercise (NDA).
Thomas Lynch, Chairman and Manager Executive Officer of Amarin, commented "Receiving FDA agreement on the Leaf 3 trial represents an important milestone for Amarin. We now case forward to commencing this Chapter 3 evaluation shortly."
Pursuant to the SPA, the Phase 3 research testament be a multi-center, placebo-controlled, randomized, double-blind, 12-week discover to evaluate the efficacy and safety of two doses of AMR101, a prescription grade Omega-3 fatty acid, in patients with fasting triglyceride levels of â 500 mg/dL (the AMR101 MARINE Study). The influential endpoint in the analysis is the percentage pin money in triglyceride level from baseline to week 12. Following completion of the 12-week double-blind treatment period, patients will be eligible to enter a 40-week, open-label, interval period.
The trial is expected to enrol approximately 240 patients, with enrollment planned to commence in mid-2009. The probation will be conducted in centers throughout North and Central America, Europe, India and South Africa. The Company plans to use the results of this Phase 3 registration trial as the justification for the submission of an NDA to the FDA.
In appendix to the AMR101 MARINE study, Amarin is further planning to govern a Event 3 trial with AMR101 in patients with high triglyceride levels (â 200 mg/dL and â 500 mg/dL) who are on statin therapy.
Amarin has worked closely with its Cardiovascular Advisory Group in designing these trials. The Advisory Group, consisting of valuable experts in the field of cardiovascular disease research and development, comprises: Dr. Harold Bays, Medical Employer and President of Louisville Metabolic and Atherosclerosis Analysis Center; Professor Philip Calder, Nutritional Immunology at the University of Southampton, UK; Dr. Michael Criqui, Professor and Chief, Division of Preventive Medicine, in the Department of Family and Preventive Medicine at the University of California, San Diego School of Medicine; Dr. Meredith Hawkins, Professor of Medicine and Director of the Global Diabetes Initiative at the Albert Einstein Faculty of Medicine in Fashionable York; Dr. Sotirios Tsimikas, Professor of Medicine and Director of Vascular Medicine at the University of California, San Diego and Dr. Anthony Wierzbicki, Consultant in Chemical Pathology/Metabolic Medicine at Guy's and St Thomas' Hospitals NHS, UK.
AMR101 is an ultra-pure ethyl ester of eicosapentaenoic acid (ethyl-EPA). Amarin has developed a important protest of information on AMR101 to date. Amarin has formerly investigated AMR101 in central apprehensive manner (CNS) disorders in several double-blind, placebo-controlled studies, including Phase 3 trials in Huntington's disease. Over 900 patients posses received AMR101 in these studies, with over 100 receiving continuous treatment for one year or more. In all studies performed to date, AMR101 has shown a very good safety profile.
Numerous independent studies gain demonstrated the safety, tolerability and efficacy of ethyl-EPA in lowering plasma triglycerides in patients with high triglyceride levels of varying degrees of severity. In Japan, an ethyl-EPA prescription product has been approved for the treatment of hyperlipidemia and has been on the mart for seventeen years.
Hypertriglyceridemia refers to a example in which patients hold big blood levels of triglycerides and is associated with increased risk of heart disease. It is one element of a area of lipid disorders collectively referred to as dyslipidemia. The overall dyslipidemia population in the U.S. is believed to be in excess of 100 million, with over 10 million of those diagnosed with hypertriglyceridemia.
Amarin Society plc
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