FDA Approves Sanofi’s New Lice Treatment

The US FDA has approved Sanofi’s Sklice (ivermectin) lotion, 0.5% for the topical treatment of head lice, in patients 6 months of age and older. Sklice Lotion, according to Sanofi, treats lice in most patients with a single 10-minute application of the lotion, without nit combing.

“The approval of Sklice Lotion provides physicians and parents with a new treatment option for head lice, a condition that is notoriously frustrating to treat,” said Kenneth P. Guito, general manager, Sanofi-Topaz. “Through a unique mode of action, Sklice Lotion resolves most head lice infestations in one application, and is very well-tolerated.”

Each year in the US, head lice infest an estimated 6 to 12 million children aged 3 to 11 years. Estimates for direct and indirect costs, which include millions of lost school days and lost work for parents, are as high as $1 billion.

Formulated with ivermectin, an antiparasitic that has been used orally for more than 20 years and more than 1 billion times to treat other parasites, Sklice Lotion was developed to meet the demand for an effective, convenient head lice treatment that works differently and is well-tolerated in children, according to Sanofi.

Sklice Lotion was developed by Topaz Pharmaceuticals, which was acquired by Sanofi Pasteur in October 2011.