ParaPRO obtains FDA nod for new indication of Natroba

ParaPRO, a specialty pharmaceutical company focused on innovative anti-parasitic treatments, has received the Food and Drug Administration’s green light for Natroba (spinosad) topical suspension, 0.9% as a 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 Jan. 18, 2011.

“As a targeted topical therapy, Natroba represents the first important pharmacological advancement in scabies treatment in more than 30 years,” said 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’,” said 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.”