It’s time for a new scabies treatment.4
Only Spinosad Topical Suspension 0.9% demonstrates the latest clinical and confirmatory outcomes as defined by the FDA’s new criteria for "complete cure", and also meets the FDA’s guidance for assessment of safety for topical therapies.1-4
Learn MoreThe need for substantiated results has been unmet for thirty years.
1989
Discretionary Data
In scabies trials, "cured" outcomes were based on observational data1**
2016
New Objective Criteria
FDA puts forth new objective criteria for defining a "complete cure" of scabies2
2020
Guidance For Topical Drugs
FDA issues guidance for topical therapies based on dermal safety studies3
**Oral Ivermectin is not FDA-approved for the treatment of scabies infestations.
Targeted topical therapy: the patented-approach of
Spinosad Topical Suspension 0.9%.
See how spinosad, the active compound in Spinosad Topical Suspension 0.9%, has a MOA that defines targeted topical therapy5,6
- Not systemically absorbed
- No neurotoxicity
- No documented resistance challenges
The therapeutic challenges with other treatment options date back more than 30 years.
- FDA -approved active pharmaceutical ingredient (API), is systemically absorbed and lipophilic7
- Deposits in fat-containing organs (brain, lungs, heart, liver and kidneys)7
- Data suggest that resistance is increasing8-11
- FDA-approved API, and indicated only for second-line treatment12
- Systemically absorbed and lipophilic13-15
- Deposits in fat-containing organs (brain, lungs, heart, liver and kidneys)13-15
- Not FDA-approved API for use with scabies13-15
- Systemically absorbed and lipophilic13-15
- Deposits in fat-containing organs (brain, lungs, heart, liver and kidneys)16
- Data suggest that resistance is increasing17,18
Reference(s)
- Elimite (permethrin) Cream, 5% (NDA 19-855) FDA Approval Leer [Leer wrien August 25, 1989 to Burroughs Wellcome Company].(1989). U.S. Food and Drug Administration. Division of Anti-Infective Drug Products.
- ParaPRO, LLC & Concentrics Research (2018). A Phase 3, Randomized, Double Blind, Placebo-Controlled Study to Assess the Safety, Efficacy and Pharmacokinetics of Spinosad Topical Suspension 0.9% for the Treatment of Scabies (Clinical Study Protocol, Amd. 6.0, pp. 1-66).
- Center for Drug Evaluation and Research. (2020, March). Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance for Industry. U.S. Food and Drug Administration https://www.fda.gov/regulatory-information/search-fda-guidance-documents/contact-dermatitis-topical-drug-products-cutaneous-application-human-safetyassessment-guidance.
- Spinosad Topical Suspension 0.9% Prescribing Information.
- Data on file, ParaPRO, LLC.
- Spinosad Technical Bulletin Dow AgroSciences LLC (Now Corteva agriscience), Form No. Y45-000-001 (01/01) CBK.
- van der Rhee et al., 1989.
- Cohen PR. Cureus. 2020;12(3):e7419.
- Meyersburg D et al. J Dermatolog Treat. 2020 Jun 4 [epub].
- Khalil S et al. PLoS Negl Trop Dis. 2017;11(11):e0005920.
- Mounsey KE et al. Future Microbiol. 2008;3(1):57-66.
- CDC website. https://www.cdc.gov/parasites/scabies/health_professionals/meds.html. Accessed July 31,2021.
- Fox SM. Pediatric EM Morsels website. https://pedemmorsels.com/scabies. Accessed July 31,2021.
- Chandler DJ, Fuller LC. Dermatology. 2019;235(2):79-90.
- Wooltorton E. CMAJ. 2003;168(11):1447-1448.
- Golant AK, Levitt JO. Pediatr Rev. 2012;33(1):e1-e12.
- Currie BJ et al. Clin Infect Dis. 2004;39(1):e8-12.
- Thomas J et al. BMC Infect Dis. 2015;15:250.
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