Nastech's Nascobal Cleared In USA

Nastech Pharmaceutical has finally been granted approval by the US Food and Drug Administration to market its Nascobal (cyanocobalamin) gel for intranasal administration in patients with vitamin B12 deficiency including pernicious anemia.

Current therapy involves the injection of vitamin B12 by a health care professional, whereas this formulation allows patients to self-administer the product intranasally, where it is absorbed across the nasal mucosa. Patients should be monitored at one month following treatment initiation, and then every three- to-six months thereafter to ensure that blood levels are maintained.

Nascobal will be available in 5ml bottles at a dose of 500mcg, but a pricing and marketing strategy has yet to be decided. This is because the approval "came as a bit of a shock," said a spokesman for the company, as it filed for clearance in 1988.