naturopathydigest.com -- Two New Botanical Drugs: Omacor and Veregen

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Two New Botanical Drugs: Omacor and Veregen

By Ronald Steriti, ND, PhD

An article on hypertriglyceridemia was published in a recent issue of American Family Physician, a peer-reviewed medical journal that summarizes research on both conventional and alternative medicine.¹

This article is very interesting in that it reflects recent changes in conventional medicine, which is becoming more favorable to alternative therapies. It also exemplifies changes in the dietary supplement industry, following new FDA guidelines.
The article compares the efficacy of statins, fibrates, niacin and fish oil for the treatment of hypertriglyceridemia. Niacin and fish oil have very favorable results, which are equivalent to, or better than, drugs. Of particular interest to alternative medicine practitioners is the dose of fish oil: 2 to 4 grams of total EPA/DHA daily.
Omacor
The article also mentions Omacor, the first FDA-approved prescription omega-3 fatty acid product which, along with diet, has been proven and approved to dramatically reduce very high triglycerides (TGs) (500 mg/dL) in adult patients. Omacor is a product of Reliant Pharmaceuticals.^2-4
Veregen
Veregen (polyphenon E, kunecatechins) is a special extract of green tea as a prescription drug for the topical (external) treatment of genital warts caused by the human papilloma virus (HPV). Veregen was developed by MediGene, a German company, and will be marketed in the United States by Bradley Pharmaceuticals of Fairfield, NJ.⁵
Botanical Drug Products
Omacor and Veregen were approved as botanical drug products under the FDA guidance published in 2004. The FDA Botanical Drug Product guidance covers several issues, including:

when a botanical drug may be marketed as an over-the-counter (OTC) drug;
when FDA regulations require approval for marketing of a new drug application (NDA), submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(b); and
guidance on submitting investigational new drug applications (INDs) for botanical drug products, including those botanical products (or botanicals) currently lawfully marketed as foods (including conventional foods and dietary supplements) in the United States.

Summary
Relatively speaking, alternative and complementary medicine is in its formative stages in the United States. There are some aspects of the German model, where natural therapies are available both over the counter (i.e., dietary supplements) and as prescription medications (i.e., botanical drugs).
References

Oh, RC, Lanier JB. Management of hypertriglyceridemia. Am Fam Physician, 2007;75:1365-72.
Bays H. Clinical overview of Omacor: a concentrated formulation of omega-3 polyunsaturated fatty acids. Am J Cardiol, 2006;98(4A):71i-6i.
Durrington PN, Bhatnagar D, Mackness MI, et al. An omega-3 polyunsaturated fatty acid concentrate administered for one year decreased triglycerides in simvastatin treated patients with coronary heart disease and persisting hypertriglyceridaemia. Heart, 2001;85(5):544-8.
Harris WS, Ginsberg HN, Arunakui N, et al. Safety and efficacy of Omacor in severe hypertriglyceridemia. J Cardiovasc Risk, 1997;4(5-6):385-91.
Ahn WS, Yoo J, Huh SW, et al. Protective effects of green tea extracts (polyphenon E and EGCG) on human cervical lesions. Eur J Cancer Prev, 2003;12(5):383-90.

About the Author: Dr. Ronald Steriti graduated from Southwest College of Naturopathic Medicine and currently resides in Naples, Fla. He can be contacted via e-mail at ron@naturdoctor.com.