FDAnews

PIEDMONT'S LICE DRUG OK'D TO MOVE TO PHASE III TRIAL

Piedmont Pharmaceuticals has received approval from the FDA to begin a Phase III trial of its head lice treatment drug known as Resultz. The trial will test the drug's safety and efficacy, which have already been demonstrated in Phase I and II trials, on a wider population.

Resultz is a noninsecticide-based drug different than the major head lice treatments currently on the market, which are generally based on active ingredients lindane or malathion. Those substances are chemically toxic to lice, but human safety concerns have led the FDA to require a boxed warning on products that contain some such ingredients.