Arbor Pharmaceuticals has launched xylitol (Xylarex) oral solution for the dietary management of recurrent acute otitis media (RAOM) in children. Available by prescription only, xylitol is intended to be administered daily to reduce the number of ear infections children experience, decreasing the need for antibiotic treatment and thus addressing concerns about the development of bacterial resistance. This product can be administered to children as young as 6 months of age.
According to labeling, RAOM is defined as “3 or more distinct, well-documented episodes of AOM within 6 months or 4 or more episodes within 12 months, with one of the episodes occurring recently.” The package insert also explains that “adding high levels of xylitol to the daily diet of RAOM-prone children helps them maintain a healthy balance of microflora in their upper airways,” the lack of which makes them susceptible to AOM. Labeling adds that “specific oral bacteria are not sustained in the presence of xylitol and are therefore less available to affect the upper airway microflora.”
In a double-blind, randomized, placebo-controlled study involving patients 7 months of age and older, children receiving 10 g of xylitol daily for 3 months (n = 324) experienced a 30% cumulative decrease in the occurrence of AOM episodes compared to the children in the control group (n = 165) who received a placebo (p = 0.006). The cumulative occurrence of the first attack of AOM during the 3-month monitoring period was significantly lower in the treated group than in the control group.
A separate 3-month, placebo-controlled study of the tolerability and acceptability of xylitol was also conducted, in which 120 children (ages 6 to 36 months) were randomized to 4 groups: xylitol solution 5 g three times daily or 7.5 g once daily, or placebo solution three times or once daily. The most common adverse reactions observed in this study with the daily dietary intake of oral xylitol were excessive gas and loose stools/diarrhea, but according to product labeling, “The number and proportion of children consuming daily dietary xylitol experiencing these symptoms did not differ significantly from children consuming daily placebo solution.” Another study found that abdominal discomfort observed in children 6 months to 6 years of age was comparable between the xylitol and control groups.
Xylitol oral solution should be consumed as part of the daily diet. The recommended intake is 1 teaspoon (5 ml) three times daily after meals and/or snacks, for a total of 3 teaspoons (15 ml) daily. It is slightly sweet tasting with natural berry flavoring.