Nascobal, the drug produced by Nastech Pharmaceutical and designed to treat vitamin B12 deficiency, has been granted approval by the FDA for use in the treatment of patients suffering from HIV, AIDS, multiple sclerosis and Crohn's disease.
Nascobal, which has been distributed in the US by German company Schwarz Pharma since 1997, is a nasally-delivered drug designed to maintain vitamin B12 levels. The approval of the extended use of the drug came after a number of clinical studies which showed that Nascobal was effective in maintaining vitamin B12 levels among sufferers of the four diseases.
Crohn's disease can cause inflammation of the intestines, making it hard for sufferers to absorb the vitamin, but the nasal delivery technique used by Nascobal bypasses this problem and makes it a more effective way of increasing intake of the vitamin than supplements, the company said.
Studies have also shown that HIV sufferers are less likely to see their condition develop into full-blown AIDS if they have higher serum vitamin B12 levels, while low levels of the vitamin in multiple sclerosis sufferers have been linked to demyelination, the destruction of the sheath which protects nerve cells and can cause neurological problems.
"We are extremely pleased that the FDA has approved a broader label for Nascobal," said Steven C. Quay, chairman of Nastech. "Nastech has identified important market opportunities for Nascobal and is exploring ways to significantly grow the product."
He said that 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, while between 10 and 20 per cent of the 800,000 HIV and AIDS patients are also classified as vitamin B12 deficient and 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 co-ordination and difficulty walking. Vitamin B12 deficiency may lead to anaemia, intestinal problems and irreversible nerve damage.