Abstract
Background & Aims: Methylcobalamin nasal spray (NasoB12® ) has been developed to overcome the drawbacks of currently available therapeutic options like the poorly absorbed oral route and the painful intramuscular route. The present study was designed to evaluate the safety and efficacy of NasoB12® in patients with Vitamin B12 deficiency, with serum vitamin B12 (svB12) <200 pg/mL (148 pmol/L).
Highlights
Vitamin B12 (B12, known as cobalamin) is a B vitamin that has an important role in cellular metabolism, especially in DNA synthesis, methylation and mitochondrial metabolism [1]
The administration of B12 by the nasal route has a 70-year history, starting from nasal drops used for treating patients suffering from pernicious anemia [8] to cyanocobalamin nasal spray in the recent decades
In a first-in-human randomized, single-dose, two-way crossover comparative bioavailability study conducted at a CRO for global regulatory approvals, it was found that the relative bioavailability of NasoB12® was 20% that of intramuscular methylcobalamin (Clinical Trial Registry: CTRI/2015/04/005687)
Summary
Vitamin B12 (B12, known as cobalamin) is a B vitamin that has an important role in cellular metabolism, especially in DNA synthesis, methylation and mitochondrial metabolism [1]. Serum vitamin B12 (svB12) levels, that are low (
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