Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), announced that the U.S. Food and Drug Administration (FDA) has approved Vermox chewable (mebendazole chewable 500mg tablets) for the treatment of patients one year of age and older with gastrointestinal infections caused by Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm).

“Roundworm and whipworm are among the most prevalent forms of intestinal parasitic infections afflicting children in the world today, particularly in vulnerable and neglected communities,” said Paul Stoffels, M.D., chief scientific officer, Johnson & Johnson. “The FDA approval of VERMOXTM CHEWABLE represents an important milestone in our efforts to develop a new therapy that safely cures patients with intestinal infections by roundworm and whipworm. We will work with the World Health Organization (WHO), other health authorities and partners to ensure Vermox Chewable is available as part of our longstanding global product donation program.”

Approval for Vermox Chewable came after the FDA granted Orphan Drug designation and Priority Review for the new treatment, shortening the dossier review period from 10 months to six months.

The introduction of a chewable formulation of mebendazole meets a recognized global health need and is an important part of Johnson & Johnson’s R&D commitment as a signatory to the 2012 London Declaration on Neglected Tropical Diseases (NTDs). Following FDA approval and eventual WHO prequalification of the Vermox Chewable tablet, Johnson & Johnson plans to include the chewable version in its donation program to help reduce the burden of intestinal worms, or soil-transmitted helminths (STH), in endemic countries. Presently, there are no plans to make Vermox Chewable commercially available.

The efficacy of Vermox Chewable was evaluated in a double-blind, randomized, placebo-controlled trial conducted in three African countries (Tanzania, Ethiopia, Rwanda) in 295 pediatric patients between the ages of 1 to 16 years with roundworm and/or whipworm infections. This trial was not designed to study the effect of mebendazole on hookworm, another STH.

Patients received a single dose of mebendazole 500mg chewable tablet or matching placebo at day 1 (double-blind period). Clinical cure was defined as zero egg count at the end of the double-blind period (Day 19) in patients with a positive egg count at baseline. At day 19, 72 out of 86 patients (84%) with roundworm infection and 42 out of 124 patients with whipworm infection (34%) were cured on mebendazole, versus 9 out of 81 (11%) with roundworm and 9 out of 119 (8%) with whipworm on placebo. The differences in cure rate between mebendazole and placebo were statistically significant (P<0.001). The Warnings and Precautions for Vermox Chewable include convulsions in infants below the age of 1 year, neutropenia and agranulocytosis and serious skin reactions with the concomitant use of mebendazole and metronidazole (see Important Safety Information). Adverse reactions reported in 6,276 (adult and pediatric) patients treated with various mebendazole formulations and dosages include gastrointestinal symptoms (anorexia, abdominal pain, diarrhea, flatulence, nausea and vomiting) and rash.

Since 2006, Johnson & Johnson has provided mebendazole tablets as part of a major donation project through Children Without Worms (CWW), a partnership between Johnson & Johnson, GSK and The Task Force for Global Health that supports global efforts to reduce the burden of parasitic infections in children. To date, Johnson & Johnson has donated more than 1 billion doses of mebendazole and plans to donate up to 200 million doses each year through 2020 as part of its commitment to London Declaration. Together with a major annual donation of albendazole by GSK, this donation program has had a major impact on providing treatment to over 75% of the 870 million at risk children targeted by the WHO.

“Roundworm and whipworm infect millions of children, most without reliable access to safe drinking water and good sanitation,” said Dr. David Addiss, Director of CWW. “A chewable form of mebendazole fills a major gap in global treatment efforts against intestinal worms and helps us treat children when they are most vulnerable to these debilitating infections.”

Vermox Chewable can be administered in two different ways: It can be chewed and then swallowed by children without the need for water. Or, by adding a small amount (2 mL to 3 ml) of drinking water to the tablet in a spoon, within two minutes, the tablet turns into a soft mass with semi-solid consistency, which can then be swallowed. Vermox Chewable tablets must be chewed completely before swallowing and must not be swallowed whole.

The development of the new chewable tablet responds to recommendations by the WHO calling for a more child-friendly formulation of mebendazole to effectively treat young children and their families. The WHO recommends tablets should be crushed and administered to young children; older children should be encouraged to chew tablets.

Soil-transmitted helminthiasis (STH) is one of the most common infections worldwide, infecting 2 billion people often living in the most underserved communities. STH is transmitted by eggs present in human feces, which can contaminate the soil in areas where sanitation is poor.

STH can affect both children and adults; however, children are more at risk. Over 270 million preschool-age children and more than 600 million school-age children live in endemic areas and are in need of treatment interventions such as safe water and sanitation. The most common species that affect people are Ascaris lumbricoides (roundworm), Trichuris (whipworm) and hookworm. STH can also lead to poor school performance in children. Recovery from STH-associated morbidity is a long term process.

To help lower the STH disease burden, the WHO recommends that preventative chemotherapy programs, also called mass drug administration programs, are carried out on a routine basis (in many cases twice a year) for at-risk people, particularly children, living in endemic areas.

STH particularly impairs physical and cognitive development of affected children. It can also lead to health complications such as intestinal bleeding, loss of appetite, diarrhea and reduced absorption of micro- and macro-nutrients. In severe cases, STH can cause complications such as intestinal obstruction. It is important to keep worm burdens as low as possible to prevent morbidity and protect children during the critical phase of their development.

Vermox Chewable (mebendazole chewable 500mg tablets) is indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm).

There are several registered formulations of mebendazole marketed by Janssen worldwide. Janssen’s 500mg Vermox solid oral tablet is currently used in the mass treatment of single or mixed intestinal infections by whipworm, roundworm and Ancylostoma duodenale and Necator americanus (hookworm).

Mebendazole interferes with cellular tubulin formation in intestinal worms which leads to the death of the worm.