Pharmacy Drugs
Recent Posts
- EPIX Pharmaceuticals Announces FDA Approval Of A Physician-Sponsored IND For Fourth 6-month Open Label Extension Of PRX-03140 For Alzheimer’s Disease
- Miriam Hospital Researcher Receives More Than $12 Million To Study Weight Control
- Novel HIV Drug To Be Studied In Cell Cultures And Patients
- ISCTM Meeting Discusses Clinical And Regulatory Aspects Of Using Adaptive Designs In Clinical Trials For Central Nervous System Drug Approvals
- Evaluation Of The Cost Effectiveness Of Implantable Blood Pressure Device
Random Posts
- Trinam(R) Phase III Study Enrols First Patient
- Drug Companies Defend Acetaminophen as FDA Considers Restrictions
- Mckesson Corporation Signs On As Leadership Supporter For ASHP's Pharmacy Practice Model Initiative
- Medical Food Reduces Medical Costs And Use Of Anti-Convulsant Medication
- Data From Enzo Therapeutics' Phase II Study Of Crohn's Disease Presented At Prestigious Gastroenterology Conference
- Manufacturers Who Conceal Data Are Harming Patients And Hindering The Work Of IQWiG And The G-BA
- LATITUDE Pharmaceuticals Initiates Two More Collaboration Studies For Its PG Depot
- Study Uncovers How Tiny Levels Of Carbon Monoxide Damage Fetal Brain
- Fifteen Approved Active Pharmaceutical Ingredients Added To Pharmaceutical Substances Version 3.2
- Immunology Expert At Children's Hospital Receives APS Prize For Patient-oriented Research
Amarin Receives Special Protocol Assessment Agreement From The FDA For Phase 3 Cardiovascular Trial
Posted by: admin in Pharmacy, Pharmacy Drugs on May 08th, 2009
Amarin Corporation plc (NASDAQ:AMRN) announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for its planned Phase 3 registration clinical trial of AMR101 (ethyl-EPA) in patients with hypertriglyceridemia, or very 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 analysis of the Phase 3 trial to be used in support of a New Drug Application (NDA).
Thomas Lynch, Chairman and Chief Executive Officer of Amarin, commented “Receiving FDA agreement on the Phase 3 trial represents an important milestone for Amarin. We now look forward to commencing this Phase 3 trial shortly.”
Pursuant to the SPA, the Phase 3 trial will be a multi-center, placebo-controlled, randomized, double-blind, 12-week study 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 ?500 mg/dL (the AMR101 MARINE Study). The primary endpoint in the trial is the percentage change 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, extension period.
The trial is expected to enroll approximately 240 patients, with enrolment planned to commence in mid-2009. The trial 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 basis for the submission of an NDA to the FDA.
In addition to the AMR101 MARINE study, Amarin is also planning to conduct a Phase 3 trial with AMR101 in patients with high triglyceride levels (?200 mg/dL and ?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 leading experts in the field of cardiovascular disease research and development, comprises: Dr. Harold Bays, Medical Director and President of Louisville Metabolic and Atherosclerosis Research 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 College of Medicine in New 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.
About AMR101
AMR101 is an ultra-pure ethyl ester of eicosapentaenoic acid (ethyl-EPA). Amarin has developed a substantial body of data on AMR101 to date. Amarin has previously investigated AMR101 in central nervous system (CNS) disorders in several double-blind, placebo-controlled studies, including Phase 3 trials in Huntington’s disease. Over 900 patients have 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 have 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 market for seventeen years.
About Hypertriglyceridemia
Hypertriglyceridemia refers to a condition in which patients have high blood levels of triglycerides and is associated with increased risk of heart disease. It is one component of a range 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.
Source
Amarin Corporation plc
No Comments »
No comments yet.
RSS feed for comments on this post. TrackBack URL
Leave a comment
You must be logged in to post a comment.