03 Jul 2002
The FDA has approved a labeling supplement to Nastech Pharmaceutical's Nascobal NDA. It states that Nascobal can be used in patients with HIV, AIDS, multiple sclerosis and Crohn's disease; conditions which can result in vitamin B12 deficiency, and for which Nascobal is indicated to maintain hematologic status. Nascobal is FDA approved and has been marketed in the US by Schwarz Pharma since 1997.
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 non-injection delivery system. Compared to 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's disease may have difficulty absorbing vitamin B12," stated Rodger L DeRose, president and CEO of the Crohn's & Colitis Foundation of America, in a media release. "For these patients, Nascobal may offer a more convenient way to receive supplements of this important nutrient."
In the US alone there are approximately 500,000 patients with Crohn's disease, of which approximately 175,000 are candidates for vitamin B12 therapy. Among the nation's 800,000 HIV and AIDS patients, between 10 and 20%, or 80,000 to 160,000 people are vitamin B12 deficient.
Finally, over 350,000 people in the US 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.
© 2002, DataMonitor