Janssen Pharmaceuticals, Inc., announced it has submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application for a 500mg chewable tablet formulation of mebendazole. If approved, mebendazole chewable tablets will provide a treatment alternative for adults and children aged one year or older with single or mixed soil-transmitted helminthiasis (STH), and address an unmet need for children too young to swallow a solid tablet.
This submission responds to recommendations by the World Health Organization (WHO) calling for a more child-friendly formulation of mebendazole to effectively treat young children, their families and communities. Specifically, the WHO recommends only chewable deworming tablets be given to children under five years, and that chewable tablets be mixed with water in children under three years.1
If approved, Johnson & Johnson aims to replace its current mebendazole solid tablet with the 500mg chewable tablet in the VERMOXTM (mebendazole) donation program, providing free access to this treatment for people in high burden countries.
The FDA submission is supported by data from 712 patients across four clinical trials2 in children and adults with single or mixed intestinal worm infestations. The results of these trials are consistent with the safety and efficacy of all currently registered mebendazole dosage forms which have been used for more than 45 years.
