The Food and Drug Administration (FDA) has approved NatrobaTM (spinosad) topical suspension for the treatment of scabies infestations in patients 4 years of age and older.
The approval was based on data from 2 multicenter, randomized, double-blind, vehicle-controlled phase 3 trials (ClinicalTrials.gov: Trial 1 [NCT02485717], Trial 2 [NCT02485704]) that assessed the efficacy and safety of Natroba in 533 patients from 206 households in which the youngest household member had an active scabies infestation. All household members were treated with either Natroba or vehicle, whether or not the member had an active scabies infestation.
Patients applied a single application of Natroba or vehicle on day 1, then returned for evaluation on day 28. The primary endpoint was the proportion of primary patients (defined as the youngest infested household member) who achieved complete cure 28 days after treatment.
Findings from Trial 1 showed that 69.8% (n=30/43) of patients treated with Natroba achieved complete cure at day 28 compared with 46.5% (n=20/43) of patients treated with vehicle (estimated difference, 22.7%; 95% CI, 1.8-43.5). In Trial 2, 83.9% (n=52/62) of patients treated with Natroba achieved complete cure at day 28 compared with 34.5% (n=20/58) of patients treated with vehicle (estimated difference, 49.7%; 95% CI, 36-63.5).
As for safety, Natroba was well tolerated with the most common adverse reactions (>1%) being application site irritation (pain and burning) and dry skin.
“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 1 application of study drug.”
Natroba, a pediculicide, is also indicated for the topical treatment of head lice infestations in patients 6 months of age and older. The product is supplied as a suspension containing 9mg of spinosad per gram in a 120mL bottle.
- FDA approves expanded indication for Natroba™ (spinosad) topical suspension, 0.9% for the treatment of scabies. [press release]. Carmel, IN: ParaPRO; April 28, 2021.
- Natroba [package insert]. Carmel, IN: ParaPRO, LLC; 2021.