ALPHARETTA, Ga., Mar 14, 2005 (BUSINESS WIRE) -- First Horizon Pharmaceutical(R) Corporation (FHRX) today announced the introduction of OptiNate(TM), a premium prescription prenatal vitamin with an innovative, all-natural, vegetarian-sourced omega-3 fatty acid predominantly in the form of DHA. OptiNate complements First Horizon's Prenate Elite(TM), the number-one prescribed prenatal vitamin in the United States.
Americans are being urged to include more omega-3 fatty acids in their diets, especially docosahexaenoic acid, or DHA. Of particular importance for pregnant women is DHA, a member of the omega-3 family. Studies suggest that DHA offers a number of benefits to the developing fetus, including enhanced cognitive development, visual acuity and nervous system maturity.(1-6)
"Pregnant women should ensure that the prenatal vitamins and supplements they take have an adequate amount of DHA," says James A. McGregor, MD, Visiting Professor of Ob/Gyn at the Keck School of Medicine of the University of Southern California, Los Angeles. "All women considering pregnancy and who are pregnant or breast-feeding should obtain nutritional supplementation containing optimal amounts of omega-3 fatty acids, folate, and other micronutrients, along with excellent baseline nutrition."
DHA is found mainly in fatty fish such as salmon and tuna, but most Americans get inadequate amounts in their diets. An added concern is that both the U.S. FDA and the Environmental Protection Agency advise women who are pregnant or may become pregnant to limit their intake of these and certain other types of fish due to a concern over ocean-borne contaminants.(7)
OptiNate fills the need for a non-fish source of DHA as part of a comprehensive prenatal nutrition regimen. Unlike other prenatal vitamins, the DHA in OptiNate is derived from an all-natural, vegetarian source -- the same DHA source used in infant formulas and the only DHA source granted Generally Recognized As Safe (GRAS) status for use in infant formulas by the Food and Drug Administration.(8) Additionally, OptiNate contains the highest concentration of DHA available in a prescription prenatal vitamin. Dr. McGregor states that, "By optimizing nutrition, today's women can take active steps to enhance each baby's brain development and neurocognitive functioning."
"We formulated OptiNate to offer pregnant women -- and women who plan to become pregnant -- an alternative way to take advantage of the benefits of DHA," remarks Lori Erlandson, First Horizon's Senior Director of Women's Health. "OptiNate contains the same DHA source used in infant formulas -- the closest DHA match to breast milk.(9) Its proprietary formulation reduces concerns about ocean-borne contaminants that may be associated with fish."
Another unique feature of OptiNate is that it is also the only prescription prenatal vitamin containing both vegetarian-sourced DHA and Metafolin(R), a patented compound that is a biologically active form of folate. Folate helps reduce the risk of a serious group of birth defects known as neural tube defects (NTDs). NTDs include such devastating abnormalities as spina bifida, in which the spinal column fails to close properly, and anencephaly, a severe underdevelopment of the brain. Foods and vitamins that are fortified with folate usually contain folic acid, a synthetic form of folate. But folic acid must undergo a complex metabolic process that reduces the folic acid to an active folate form, 5-Methyl THF, before it can be used by the body, and studies show that up to 1 in 2 women have a genetic variation that interferes with their ability to break down folic acid to this active folate form.(10) Without sophisticated and expensive genetic testing, which is not routinely performed, those women who are unable to completely metabolize folic acid remain unidentified. Metafolin, which already is the active form of folate, needs no further metabolism - it is immediately available for use by the body.
Commenting on the announcement, Patrick Fourteau, Chief Executive Officer and President of First Horizon, said, "OptiNate is an excellent expansion of our very successful Prenate Stages line of prenatal vitamins. We believe OptiNate is a major advancement in prenatal nutrition and will be well received in the medical community."
First Horizon Background
First Horizon Pharmaceutical(R) Corporation is a specialty pharmaceutical company that markets and sells prescription products with a primary focus on cardiology and women's health. First Horizon has a portfolio that includes 13 branded prescription products of which 5 are actively promoted to high-prescribing physicians through its nationwide marketing and sales force of approximately 360 representatives. First Horizon's Web site address is http://www.fhrx.com. Please visit First Horizon's Web site for full prescribing information on First Horizon's products.
Safe Harbor Statement
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding First Horizon Pharmaceutical Corporation's business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report or Form 10-K for the most recently ended fiscal year.
Important Safety Information
Folic acid may mask the symptoms of certain forms of anemia not related to iron deficiency. The most common side effects from taking prenatal vitamins may include upset stomach, nausea, and abdominal cramps. Women taking folic acid may experience allergic reactions and sensitization to folic acid.
Warning: Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.
Warning: Accidental overdose of iron-containing products is a leading
cause of fatal poisoning in children under 6. Iron-containing products
should always be kept out of reach of children. In case of accidental
overdose, call a doctor or poison control center immediately.
(1) Innis SM, Gilley J, Werker J. Are human milk long-chain polyunsaturated fatty acids related to visual and neural development in breast-fed term infants? J Pediatr. 2001;139(4):532-538.
(2) Uauy R, Hoffman DR, Mena P, Llanos A, Birch EE. Term infant studies of DHA and ARA supplementation on neurodevelopment: results of randomized controlled trials. J. Pediatr. 2003;143(4suppl):517-525.
(3) Horrocks LA, Yeo YK. Health benefits of docosahexaenoic acid (DHA). Pharmacol Res. 1999;40:211-225.
(4) Birch EE, Garfield S, Hoffman DR, Uauy R, Birch DG. A randomized controlled trial of early dietary supply of long-chain polyunsaturated fatty acids and mental development in term infants. Dev Med Child Neurol. 2000;42(3):174-181.
(5) Voigt RG, Jensen CL, Fraley JK, Rozelle JC, Brown FR III, Heird WC. Relationship between omega3 long-chain polyunsaturated fatty acid status during early infancy and neurodevelopmental status at 1 year of age. J Hum Nutr Diet. 2002;15(2):111-120.
(6) Helland IB, Smith L, Saarem K, Saugstad OD, Drevon CA. Maternal supplementation with very-long-chain n-3 fatty acids during pregnancy and lactation augments children's IQ at 4 years of age.Pediatrics.2003;111:e39-e44.
(7) U.S. Food and Drug Administration and U.S. Environmental Protection Agency. What You Need to Know About Mercury in Fish and Shellfish. Rockville, Md: Joint FDA/EPA/CFSAN publication;2004. Publication number EPA-823-F-04-009.
(8) U.S. FDA GRAS Notice No. GRN 000041.
(9) Data on file, Expert Panel.
(10) Kirke, PN, Mills JL, Molloy AM, et al. Impact of the MTHFR C677T polymorphism on risk of neural tube defects: case-control study. BMJ (serial online). 2004;328(7455):1535-1536. Available at: http://bmj.bmjjournals.com/cgi/content/full/328/7455/1535. Accessed September 28, 2004.