Janssen Pharmaceuticals, a unit of Johnson & Johnson ($JNJ), has submitted a new drug application to the FDA for a 500-milligram chewable tablet targeting intestinal worms in children one year or older.
The new formulation of mebendazole is in response to the World Health Organization’s call for a more child-friendly version of the drug that can be chewed or can be mixed with water and swallowed, the company said. The current registered forms of the drug have been in use for more than 45 years.
Mebendazole is used to treat single or mixed soil-transmitted helminthiasis, which affects about two billion people globally, mostly in developing countries. The disease, which is commonly carried by roundworm, whipworm and hookworm, is transmitted by eggs present in human feces that can contaminate soil in areas where there is poor sanitation.
“The tablet can be chewed by children over five years without need of potable water,” Dr. Wim Parys, Janssen’s global head of Public Health, said in a statement. “When mixed with water, it forms a soft mass, allowing the treatment to be extended to children as young as one year of age who cannot be given a solid tablet.”
If the regulatory agency approves the drug, it would replace the current solid tablet in the Vermox (mebendazole) donation program, providing free access to the treatment in targeted countries. Janssen’s FDA submission is supported by data from 712 patients across four clinical trials.