Discover Why The FDA Has Redefined Efficacy as A “Complete Cure” for Scabies.
After more than 30 years of prescribing the same agents for scabies1—including those with known limitations such as toxicity, AEs, resistance, and treatment failure2,3—the FDA has redefined the criteria for a “complete cure,” which includes both clinical and confirmatory standards.4
In this webinar, Scabies Treatment: Challenging the Status Quo, Dr. Anthony Mancini, Chief of Dermatology in the Department of Pediatrics at the Northwestern University Feinberg School of Medicine, explores the need for targeted topical therapies that improve safety, efficacy, and tolerability while avoiding resistance to meet the new FDA criteria.
Explore the clinical background regarding:4-6
- Challenges with today’s scabies diagnostic criteria in adults and infants
- Recent updates to the FDA’s criteria for an effective scabies treatment
- Known limitations with current scabicides, including Permethrin 5%, Ivermectin Oral, and Lindane 1%
- Attributes of a novel targeted topical scabicide that could deliver a “complete cure”
to learn more about the only targeted topical therapy that meets the new FDA criteria for a “complete cure” from a scabies infestation.4
- Elimite (permethrin) Cream, 5% (NDA 19-855) FDA Approval Letter [Letter written August 25, 1989 to Burroughs Wellcome Company].(1989). U.S. Food and Drug Administration. Division of Anti-Infective Drug Products.
- Gopinath et al, Int J Dermatol. 2018; 57 (11); 1293-1298
- Khalil S et al. PLoS Negl Trop Dis. 2017;11(11):e0005920.
- ParaPRO, LLC & Concentrics Research (2018). A Phase 3, Randomized, Double Blind, Placebo-Controlled Study to Assess the Safety, Efficacy and Pharmacokinetics of Natroba™ for the Treatment of Scabies (Clinical Study Protocol, Amd. 6.0, pp. 1-66).
- Blume-Peytavi U et al. J Eur Acad Dermatol Venereol. 2019;33(suppl 1):3-36.
- Gerber DE. Am Fam Physician. 2008;77(3):311-319