CARMEL, Ind.  – ParaPRO, a specialty pharmaceutical company focused on innovative anti-parasitic treatments, today announced the availability of Natroba (spinosad) Topical Suspension, 0.9%, the first product (new drug application) for scabies to be approved by the U.S. Food and Drug Administration (FDA) in more than 30 years. Earlier this year, the company received FDA approval of its

supplemental New Drug Application (sNDA) for Natroba as a targeted topical treatment for scabies infestations 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 and is currently the most frequently prescribed treatment option.

“There are known limitations with existing scabicides, and for more than 30 years, practitioners have had to rely on the same active pharmaceutical ingredients to treat scabies,” said Bill Culpepper, resident of ParaPRO. “We are pleased to offer healthcare providers and their patients the first pharmacological advancement in scabies treatment in decades. Natroba is a targeted topical therapy that was shown to be highly effective and well-tolerated in the treatment of scabies following one application of the study drug.”

Natroba’s approval was based on the FDA’s new criteria for a “complete cure” and included data from two phase 3, multi-center, randomized, double-blind, vehicle-controlled clinical trials in patients from 206 households (533 patients) in which the youngest household member (index subject) four years of age or older had an active scabies infestation.

Since 1989, “cured” outcomes from scabicides approved by the FDA were based on investigator observation. In 2016, the FDA established new, objective criteria for determining a “complete cure” which is now defined as being both clinical and confirmatory. A scabies patient is considered cured if a practitioner determines that all signs and symptoms have completely resolved, including burrows, inflammatory/non-inflammatory lesions, and pruritus, and conducts microscopic or dermatoscopic assessments to validate the absence of mites, eggs, scybala and burrows.

“The approval of Natroba’s expanded indication is a significant advancement in the scabies treatment landscape,” said Dr. Anthony J. Mancini, Professor of Pediatrics and Dermatology, Northwestern University Feinberg School of Medicine and Head of Dermatology, Ann & Robert H. Lurie Children’s Hospital of Chicago. “There are several challenges associated with diagnosing and treating scabies, and what makes this therapeutic option unique is an entirely novel mechanism of action whereby spinosad – the active compound in Natroba – is delivered to the stratum corneum, the outermost layer of the epidermis, and targets mites at the site of infestation without penetrating deep into the dermis or entering systemic circulation. This product offers practitioners a new, proven option for the treatment of scabies.”