Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Company plans to use results as the basis for submission of new drug application to the FDA
Subscribe to our email newsletter
Amarin, an Ireland-based clinical-stage biopharmaceutical company, has reached an agreement with the FDA under a special protocol assessment for its planned Phase III registration clinical trial of AMR101 in patients with hypertriglyceridemia, or very high triglyceride levels.
Pursuant to the special protocol assessment (SPA), the Phase III 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 greater than or equal to 500mg/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 enrollment 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 III registration trial as the basis for the submission of a new drug application to the FDA.
In addition to the AMR101 Marine study, Amarin is also planning to conduct a Phase III trial with AMR101 in patients with high triglyceride levels who are on statin therapy.