FDA accepts application for Sciele/Summers novel head lice treatment

ATLANA Sciele Pharma announced that the Food and Drug Administration has accepted Summers Laboratories’ application for a head lice asphyxiation product that utilizes a novel mechanism of action.

Upon FDA approval, it will be the first prescription medication that kills head lice by asphyxiation instead of utilizing a neurotoxic pesticide. The prescription lice treatment market generated approximately $50 million in sales last year, according to IMS Health data, and Sciele estimates that the over-the-counter lice treatment market is several times larger.

Sciele reported that the new product is a simple, water-based, water-soluble gel, similar in consistency to a hair conditioner. It consists of a mixture of dermatological and cosmetic ingredients. Lice need oxygen to live and breathe through sophisticated spiracles. Lice can close their spiracles and go into suspended animation for many hours. This novel product contains a naturally occurring monohydric aralkyl alcohol, which prevents lice from closing their spiracles, thereby asphyxiating the lice within ten minutes.

Sciele acquired the rights to this product for the United States, Canada and Mexico, and Summers submitted its application for this patented treatment on June 15, 2007.