Amarin has reached an agreement with the US Food and Drug Administration under a special protocol assessment (SPA), to go ahead with the planned phase-III clinical trial of AMR101 (ethyl-EPA) for patients with mixed dyslipidemia.
This is the second SPA agreement received by Amarin for AMR101 in cardiovascular disease and follows the SPA agreement obtained in May 2009 in relation to the planned registration trial with AMR101 in patients with very high triglycerides.
Amarin chairman and CEO Thomas Lynch said that receiving FDA agreement on the phase-III trial in mixed dyslipidemia was an important endorsement of the company’s strategy, which aims to provide a more comprehensive label for AMR101.
“We plan to commence both this mixed dyslipidemia trial and the MARINE study in the third quarter of 2009, pending completion of the company’s longer term funding,” Lynch said.
The phase-III mixed dyslipidemia trial will consist of a multi-centre, placebo-controlled, randomised, double-blind, 12-week study.
The trial will evaluate the efficacy and safety of 2g and 4g of AMR101 in patients with high triglyceride levels of =200mg/dL and <500mg/dL who are on statin therapy. The primary endpoint in the trial is to record a percentage change in triglyceride level from baseline to week 12.