ParaPRO lice drug approved

ParaPRO has won approval from the US Food and Drug Administration (FDA) for Natroba (spinosad), a topical treatment of head lice infestation that can be applied in 10 minutes and requires no nit-combing.

The prescription drug, which is cleared for use in patients aged four and older, will be launched in the first half of this year.

The approval was based on two multicentre, randomised studies that compared the new drug to permethrin, the active ingredient in Insight Pharmaceutical's topical treatment Nix.  In the studies, a total of 552 subjects with head lice received a 10-minute treatment with Natroba, with some also receiving a second treatment a week later if necessary.  Most subjects treated with Natroba did not require a second application, while most treated with permethrin did need a second round.

Eighty-six per cent of the subjects treated with Natroba were lice-free 14 days after the final treatment, compared to 44 per cent of the permethrin-treated control group, according to the FDA.

Nix may still have some market advantages, however, as it can be purchased without a prescription and is approved for children as young as two months old.

There are between 6m and 12m cases of head lice infestation in the US each year, mainly in children between the ages of three and 12 years old, according to the US Centers for Disease Control and Prevention.

ParaPRO is a speciality pharmaceutical company that was formed in 2002 to acquire, develop, and commercialise proprietary products in high-potential markets.