Carmel firm gets FDA approval for lice treatment

ParaPRO LLC, a locally based specialty pharmaceutical developer, said Tuesday that the U.S. Food and Drug Administration has approved its topical treatment for head lice.

The treatment, called Natroba, is expected to be on the market later in 2011, the company said.

The new therapy is based on a compound developed at Eli Lilly and Co. called Spinosad. ParaPRO acquired rights to use it for lice treatment in 2002. The company received a $2.1 million grant from Indiana's 21st Century Research and Technology Fund in 2007 to help develop the treatment.

ParaPRO is a subsidiary of Carmel-based SePRO Corp., which makes herbicides and fungicides.

Touted as environmentally-friendly, Spinosad has a green pedigree. It's based not on a synthetic compound, but on bacteria that occur naturally in the soil. Lilly discovered the bacteria in the Caribbean in the mid-1980s.

The pharmaceutical giant eventually spun out its Agricultural Products Division in a joint venture with Dow Chemical Co. The venture, which became Dow AgroSciences, now sells a line of Spinosad-based insecticides that ring up annual sales approaching $200 million a year. They're available in 70 countries and used on 150 different crops.

According to the National Science Foundation, between 6 million and 12 million U.S. children are affected by head lice annually, resulting in outbreaks that lead to 12 million to 24 million lost school days. ParaPro hopes its Spinosad lice treatment one day will prove as successful as Dow AgroSciences' insecticides.

The company said the product will be the first available that doesn't require nit combing, the often painful, manual removal of the insects and eggs.
"ParaPRO's technology provides an easy solution to a common public health nuisance," said Mitch Roob, Indiana's secretary of commerce, in a prepared statement. "In addition to the benefits of a simplified treatment for lice, ParaPRO's product paves the way for future high-wage job creation."