More MS news articles for September 2002

Vitamin B12 Therapy: FDA approves Nascobal labeling to include HIV, AIDS, MS, and Crohn disease

August 24, 2002
Obesity, Fitness & Wellness Week

Nastech Pharmaceutical Company, Inc., (NSTK) announced that the U.S. Food and Drug Administration (FDA) has approved a labeling supplement to the Nascobal NDA that states that Nascobal can be used in patients with HIV, AIDS, multiple sclerosis, and Crohn disease, conditions which can result in vitamin B12 deficiency, and for which Nascobal is indicated to maintain hematologic status.

Nascobal (cyanocobalamin, USP) Gel for Intranasal Administration safely and effectively maintains therapeutic serum levels of vitamin B12. Nascobal can be self administered through a simple noninjection delivery system. Compared with other methods of vitamin B12 maintenance therapy, patient convenience is enhanced, as fewer physician office visits are required for maintenance therapy. "Because of intestinal inflammation, people with Crohn disease may have difficulty absorbing vitamin B12," stated Rodger L. DeRose, president and CEO of the Crohn &  Colitis Foundation of America. "For these patients, Nascobal may offer a more convenient way to receive supplements of this important nutrient."

Significant peer-reviewed published clinical research supports the importance of the maintenance of proper vitamin B12 levels in this diverse group of patients.

"We are extremely pleased that the FDA has approved a broader label for Nascobal," stated Steven C. Quay, MD, PhD, chairman, president, and CEO of Nastech. "Nastech has identified important market opportunities for Nascobal and is exploring ways to significantly grow the product."

In the U.S. alone there are approximately 500,000 patients with Crohn disease, of which approximately 175,000 are candidates for vitamin B12 therapy. Among the nation's 800,000 HIV and AIDS patients, between 10-20%, or 80,000-160,000 people are vitamin B12 deficient. Finally, over 350,000 people in the U.S. have multiple sclerosis.

Symptoms of vitamin B12 deficiency include fatigue, weakness, sore tongue, forgetfulness, weight loss, lack of coordination, and difficulty walking. Vitamin B12 deficiency may lead to anemia, intestinal problems, and irreversible nerve damage.

This article was prepared by Obesity, Fitness &  Wellness Week editors from staff and other reports.

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