Lovaza-Drug Makers Market Prescription Fish Oil-Nature Medicine 2012

Posted by:  Kevin G. Parker, D.C.

Story by:  Nature Medicine, 18: 6, 2012     Pub Med:  Nat Med. 2012 Jan 6;18(1):6. doi: 10.1038/nm0112-6

Key Points from me

Omega 3 fatty acids found in fatty fish reduce the risk of coronary artery disease by lowering dangerous blood fats.

Drug Giant GlaxoSmithKline is marketing a prescription omega 3 drug called Lovaza-with sales that approach 1 billion dollars last year.

The drug costs patients 400 dollars a month-which is considerably higher than over-the-counter omega 3’s available in health food stores. (the drug version costs at least sixfold more than over-the-counter pills)

Critics say there is little evidence that Lovaza provides any benefit over the Store versions of Omega 3’s Supplements.

Okay on with the article…

Are drugmakers fishing for a market with prescription omega-3s?-Rebecca Hersher

The market for fish oil supplements dates back more than two centuries to when British fishermen started selling the oil oozing from cod livers as a miracle cure for many ailments. Today, fish oil is enjoying a renaissance for a slew of purported health benefits, from reducing cholesterol and lessening asthma to treating dry skin and slowing aging. But, rather than pouring crude oil products from a decanter, most people nowadays tend to get their health-promoting omega-3s in the form of squishy gel-capsules containing refined fatty acids, which have grown to become the third most popular dietary supplement in the US.

Aiming to capture part of the growing market, big pharma has recently cast its hook into the fish oil frenzy. London-based GlaxoSmithKline (GSK) now offers a prescription omega-3 fatty acid pill called Lovaza, which posted sales of more than $820 million in 2010. And, on 25 November, the US Food and Drug Administration (FDA) accepted a new drug application for an omega-3 medication known as AMR101, developed by Dublin-based Amarin.

But, even as drugmakers perfect their prescription versions, some onlookers remain skeptical. “Frankly, nobody knows for sure how the prescription compares to the supplement in terms of effectiveness,” says Charles Serhan, a biochemist who studies omega-3s at the Brigham and Women’s Hospital in Boston.

Lovaza—which, at around $400 per month, costs at least sixfold more than over-the-counter pills—is a defined formulation of two different kinds of omega-3s. Importantly, its manufacturers stress, the drug is free of impurities such as heavy metals and other toxins that are sometimes found in the nonprescription supplements. In clinical trials, Lovaza has been shown to reduce circulating blood fats in people with high triglyceride levels by up to 47% (Am. J. Cardiol. 98, 71i–76i, 2006). But Lovaza, which is marketed as Omacor outside the US by a number of companies under license from the Norwegian drugmaker Pronova BioPharma, has also been shown to raise people’s levels of ‘bad’ cholesterol by a few percentage points—an adverse effect that has been linked to one of the drug’s two ingredients, docosahexaenoic acid (J. Nutr. 142, 99–104, 2012).

Regulatory concerns about this side effect have kept Lovaza from reaching a larger market. At present, the drug is approved only for those with triglyceride levels exceeding 500 milligrams per milliliter. GSK has applied twice—in 2004 and again in 2009—for the drug to be approved for people with triglyceride levels as low as 200 milligrams per milliliter of blood. In both cases, the FDA rejected the company’s application, citing the cholesterol bump.

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see the other blog articles on Fish Oil or Omega 3’s on my blog- Kevin G. Parker, D.C.

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