Drug Discovery & Development - November 10, 2010
Omthera Pharmaceuticals, Inc. announced the initiation of a randomized, open-label, four-way cross-over pharmacokinetics study to evaluate the bioavailability of Epanova, Omthera’s lead compound for the treatment of very high triglycerides, in comparison to Lovaza, the leading prescription Omega-3. Epanova is an Omega-3 fatty acid compound containing a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). The primary objective of the four-week study, called ECLIPSE (Epanova Compared to Lovaza In a Pharmacokinetic Single-dose Evaluation), is to compare the bioavailability of EPA from Epanova and Lovaza in either a low or high fat diet setting.
The study will include 50 subjects. In the four cross-over periods, all subjects will be given a single 4-gram dose of either Epanova or Lovaza with low and high fat meals. Data is expected from this study in the first quarter of 2011.
"Several studies have compared the absorption of Omega-3 fatty acids in the ethyl ester and free fatty acid forms and found that the free fatty acid form has up to four times greater bioavailability. Given that Epanova is a free fatty acid form of EPA and DHA, whereas Lovaza is an ethyl ester EPA and DHA product, Epanova may offer distinct advantages in the marketplace," said Dr. Michael Davidson, chief medical officer of Omthera Pharmaceuticals. “Further, free fatty acid Omega-3s are well absorbed when given with a low fat meal and may therefore have clinical relevance in patients with hypertriglyceridemia who should be maintained on a low fat diet.”
Epanova is a patent protected, novel, ultra-pure mixture of the free fatty acid forms of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Omthera has developed a substantial body of data on Epanova, which points to an improved and more predictable bioavailability as compared to the ethyl ester form found in prescription Omega 3 products
currently available. Triglyceride lowering with Epanova was previously observed in two large, placebo-controlled, randomized, double-blind, Phase III studies involving 748 Crohn's Disease patients with normal triglyceride levels for ≥52 weeks; approximately 400 of which were treated with Epanova for remission of disease. In all studies performed to date, Epanova has demonstrated a very good safety and tolerability profile.
Date: November 8, 2010
Source: Omthera Pharmaceuticals, Inc.
The study will include 50 subjects. In the four cross-over periods, all subjects will be given a single 4-gram dose of either Epanova or Lovaza with low and high fat meals. Data is expected from this study in the first quarter of 2011.
"Several studies have compared the absorption of Omega-3 fatty acids in the ethyl ester and free fatty acid forms and found that the free fatty acid form has up to four times greater bioavailability. Given that Epanova is a free fatty acid form of EPA and DHA, whereas Lovaza is an ethyl ester EPA and DHA product, Epanova may offer distinct advantages in the marketplace," said Dr. Michael Davidson, chief medical officer of Omthera Pharmaceuticals. “Further, free fatty acid Omega-3s are well absorbed when given with a low fat meal and may therefore have clinical relevance in patients with hypertriglyceridemia who should be maintained on a low fat diet.”
Epanova is a patent protected, novel, ultra-pure mixture of the free fatty acid forms of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Omthera has developed a substantial body of data on Epanova, which points to an improved and more predictable bioavailability as compared to the ethyl ester form found in prescription Omega 3 products
currently available. Triglyceride lowering with Epanova was previously observed in two large, placebo-controlled, randomized, double-blind, Phase III studies involving 748 Crohn's Disease patients with normal triglyceride levels for ≥52 weeks; approximately 400 of which were treated with Epanova for remission of disease. In all studies performed to date, Epanova has demonstrated a very good safety and tolerability profile.
Date: November 8, 2010
Source: Omthera Pharmaceuticals, Inc.
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