Natroba™ (spinosad) Topical Suspension, 0.9% is now approved as a topical treatment for scabies infestations in adult and pediatric patients four years of age and older. ParaPRO received approval of a supplemental New Drug Application (sNDA) for Natroba™, which has been approved for the topical treatment of head lice infestations since 2011. It is currently the most frequently prescribed treatment option for head lice.

Approval of the sNDA was based on 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—meeting FDA’s recently/newly redefined criteria for demonstrating “complete cure.”

All members of the household were treated with the same randomized treatment (Natroba or vehicle), whether or not the member of the household had an active scabies infestation. The patient applied a single application of Natroba or vehicle on Day 1 and returned for evaluation on Day 28.  Efficacy was assessed as the proportion of index subjects who achieved complete cure 28 days after treatment. Safety findings suggest the product was well-tolerated by patients as young as four years old.

“As a targeted topical therapy, Natroba represents the first important pharmacological advancement in scabies treatment in more than 30 years,” saya Bill Culpepper III, President of ParaPRO. “Combined results from our rigorous phase 3 clinical trials found that Natroba™was highly effective and well-tolerated in the treatment of scabies following one application of study drug.” 

“Older scabies medications were approved on the basis of investigator observational data to evaluate if a patient was ‘cured’,” says Dr. Christopher Belcher, Director, Pediatric Infectious Diseases, Peyton Manning Children's Hospital.  “A ‘complete cure’ has now been determined, by the FDA, to be both clinical and confirmatory, removing investigator bias and relies on objective, clinical assessments. The Natroba clinical trials were conducted in a real-life setting with patients applying the medication at home, followed by confirmation that all symptoms completely resolved, offering practitioners a new standard in the treatment of scabies.”