Topaz Pharmaceuticals LLC, a pharmaceutical company dedicated to the health and well being of children, announced today that the U.S. Food and Drug Administration (FDA) has approved an investigational new drug application; allowing Topaz to begin clinical trials of the company's topical solution for the treatment of head lice.
The Topaz product is designed to give healthcare professionals a new choice for the treatment of head lice infestations - it will provide a naturally derived treatment that is lethal to lice and nits, yet safe to children and adults. Between 6 and 12 million children are affected by head lice in the United States each year. In many cases, the children with head lice are dismissed from school and not allowed to return until they are declared "lice free" -- impacting parents and children alike.
"This IND approval and the entry of our first subjects into clinical trials bring us closer to a significant milestone in the treatment of head lice," said Nick Spring, Topaz Pharmaceuticals president and chief executive officer.
"Current treatments on the market are either becoming less effective because of lice resistance or contain potentially hazardous substances. We remain confident and optimistic that the Topaz solution will be proven safe and effective in subsequent trials, and will eventually help alleviate the frustration, inconvenience and social stigma associated with head lice."
Topaz Pharmaceuticals LLC is a start-up company, which initially benefited from support provided by the Ben Franklin Technology Partners of Southeast Pennsylvania, who develops and markets pediatric medicines.
The company expects to develop additional indications covering other parasitic insects affecting human health. Topaz Pharmaceuticals is developing a completely novel and kid friendly formulation of a naturally derived, quick acting ingredient which is lethal to head and body lice.