Xeglyze Approved to Treat Head Lice

July 27, 2020 – The U.S. FDA has approved XeglyzeTM (abametapir 0.74% lotion), manufactured by Dr. Reddy’s Laboratories, as a topical treatment for head lice infestation in patients at least six months old.

Head lice are likely to affect each person in the United States at least once in their lifetime, being one of the most common parasites found on humans. The lice are tiny, wingless insects that spend their entire lives on human scalps and survive entirely off of human blood. They spread by crawling from one head to another either through direct contact, or through the sharing of items such as hair accessories, brushes, and combs. Female lice can lay up to 10 eggs, also called nits, in a day. Many head lice are now resistant to treatment with over-the-counter products intended to treat infestations, creating a need for new treatment approaches.

In clinical trials, Xeglyze achieved treatment success in 81-82% of patients compared to 47-51% of patients receiving a vehicle control (a topical lotion similar to Xeglyze but without the active pharmaceutical ingredient). Treatment success was defined as the absence of live lice at each of a series of three follow-up visits on Days 1, 7, and 14 following treatment. If a patient had live lice at any time between treatment with Xeglyze and final evaluation, it was considered a treatment failure.

Recommended dosing is a single application of up to one full bottle applied to dry hair. Xeglyze should be massaged into the scalp and throughout the hair, then left in place for 10 minutes before being rinsed off with warm water. The product should be used in the context of an overall lice management program that includes washing (with hot water) or dry-cleaning all recently worn clothing, hats, used bedding, and towels, as well as washing personal care items such as combs, brushes, and hair clips in hot water. A fine toothed comb or special nit comb should be used to remove dead lice and nits. Launch and pricing plans are not yet available.