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A single application targets the infection without entering the circulatory system.
ParaPRO, a specialty pharmaceutical company focused on antiparasitic treatments, has announced the availability of Natroba (spinosad) Topical Suspension.
In April, the FDA approved the company’s sNDA for Natroba as a targeted topical treatment for scabies in adult and pediatric patients four years of age and older. Natroba has been approved for the topical treatment of head lice infestations since 2011.
Natroba’s approval was based on the FDA’s new criteria for a “complete cure" of scabies, a skin condition caused by mites that in adults is usually sexually acquired. For decades, whether a case of scabies was cured was determined by outcomes by investigator observation. But in 2016, the FDA established new criteria and defined a complete cure as being both clinician observation and confirmed by microscopic or dermatoscopic assessments to validate the absence of mites and eggs.
For Natroba, the two phase 3 clinical trials in patients from 206 households (533 patients) in which the youngest household member four years of age or older had an active scabies infestation. Efficacy was assessed as the proportion of index subjects who achieved complete cure 28 days after treatment.
It is dosed as a single application applied to the skin that targets mites at the site of infestation without penetrating deep into the skin or entering systemic circulation.
Mites are in the athropod class Arachnida, which includes spiders and ticks. Scabies are caused by the human itch mite (Sarcoptes scabiei var. hominis). The microscopic scabies mite burrows into the upper layer of the skin where it lives and lays its eggs. An estimated 200 million people worldwide suffer from scabies at any one time, according to the World Health Organization.
According to the Centers for Disease Control and Prevention, scabies can spread easily under crowded conditions. Nursing homes, extended-care facilities, child-care facilities, and prisons are often sites of scabies outbreaks.