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news.Amarin has commenced a Phase I safety and efficacy trial in volunteers that will evaluate the co-administration of ultra-pure ethyl EPA and niacin on niacin-induced flushing, a common side effect of niacin treatment which significantly limits patient compliance.
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Niacin is a treatment is used to increase high density lipoprotein (HDL) and modestly decrease triglyceride levels in dyslipidemia or cholesterol management. Ultra-pure ethyl EPA prescribed in Japan for over 15 years for the treatment of triglyceride lowering is known to have several additional beneficial effects in cardiovascular disease.
Amarin intends to develop its dyslipidemia and metabolic syndrome cardiovascular development pipeline and will seek partners to further develop and commercialize if efficacy is proven.
Rick Stewart, CEO of Amarin, said: “The initiation of this study is significant because it marks the commencement of Amarin’s cardiovascular development program and potentially addresses a major medical need. Niacin is a valuable addition to the treatment of dyslipidemia but its principal drawback is flushing.”