Amarin Reaches Special Protocol Assessment Agreement With FDA
Primary endpoint in the trial is the percentage change in triglyceride level from baseline to week 12
Amarin has reached an agreement with the FDA under a Special Protocol Assessment (SPA), for its planned phase-III clinical trial of AMR101 (ethyl-EPA) in patients with mixed dyslipidemia.
This is the second SPA agreement received by Amarin for AMR101 in cardiovascular disease. It follows the SPA agreement obtained in May 2009 in relation to the planned registration trial with AMR101 in patients with very high triglycerides.
Thomas Lynch, Chairman and CEO of Amarin, said: “Receiving FDA agreement on this Phase 3 trial in mixed dyslipidemia is an important endorsement of our 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, as described in our press release earlier this week.”
The phase-III mixed dyslipidemia trial will be a multi-center, placebo-controlled, randomized, double-blind, 12-week study. It is to evaluate the efficacy and safety of 2gm and 4gm of AMR101 in patients with high triglyceride levels of =200 mg/dL and <500 mg/dL who are on statin therapy. The primary endpoint in the trial is the percentage change in triglyceride level from baseline to week 12.
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