Amarin Approved for Phase III Study of Hypertriglyceridemia Drug
Amarin has the FDA’s approval to begin a Phase III study of its experimental compound AMR101 to treat hypertriglyceridemia, according to the company.
The condition is associated with increased levels of heart disease caused by high blood levels of triglycerides.
AMR101 is an ultrapure ethyl ester of eicosapentaenoic acid. It has been studied for its effect on central nervous system disorders in several double-blind, placebo-controlled studies, including Phase III trials in Huntington’s disease.
More than 900 patients have received AMR101 in these studies, and more than 100 have received continuous treatment for one year or more. The drug has shown a good safety profile in all the studies, Amarin said.