AMARIN GETS SPECIAL PROTOCOL ASSESSMENT FROM FDA
Amarin has reached an agreement with the FDA under the special protocol assessment
(SPA) procedure for the design of two pivotal Phase III clinical trials of Miraxion
in Huntington's disease. The SPA is a process under which the FDA provides evaluation
and guidance on clinical trial protocols for Phase III trials.
The U.S. and European trials will be multicenter, randomized, double-blind, placebo-controlled studies of Miraxion at 43 sites in the U.S. and up to 28 sites in Europe. The trials are expected to involve a total of up to 540 Huntington's disease patients with approximately 300 in the U.S. Phase III trial and approximately 240 in the European Phase III trial over a six-month period. Patients in the U.S. trial will participate in a further six-month extension period.