More Pediatricians Prescribe Spinosad Topical Suspension 0.9%

Spinosad Topical Suspension 0.9% is a proven safe and effective solution for resistant head lice. To date, more than 60% of pediatricians in the US have treated head lice with the compound spinosad.1

Superiority Over Nix®

Spinosad Topical Suspension 0.9% is the only FDA-approved prescription head lice treatment that demonstrated clinical superiority to Nix® (permethrin 1%) in two head-to-head, phase III clinical trials. No nit combing required2.

In two multicenter, randomized, controlled clinical studies under actual-use conditions, significantly more patients using Spinosad Topical Suspension 0.9% were lice-free (no live lice, adults or nymphs) 14 days after the last treatment without nit combing compared to permethrin with combing, 84.6% vs. 44.9% and 86.7% vs. 42.9%, respectively (P<0.001).2

chart-1
Primary Endpoint: The proportion of patients who were lice free (no live lice, adults or nymphs) 14 days after the last treatment with Spinosad Topical Suspension 0.9% without combing vs. permethrin with combing.

Safety from the Ground Up

The active ingredient in Spinosad Topical Suspension 0.9%, spinosad, derives from a naturally occurring soil microorganism3 that differs from neurotoxic agents such as permethrins and pyrethrins4:

Infographic for Spinosad
  • The compound, spinosad, is not systemically absorbed, even in patients as young as six (6) months of age5
  • Spinosad targets lice and nits where they live, never penetrating beyond the stratum corneum, before breaking down through desquamation2
    • In a Phase 1 clinical trial, 14 subjects, 4-15 years of age, applied a single topical (scalp) treatment of spinosad 1.8% (twice the active amount of the compound in Spinosad Topical Suspension 0.9%) for 10 minutes. Results demonstrated no systemic absorption of spinosad2
  • There is no evidence of neurotoxicity, developmental/reproductive toxicity, immunotoxicity, mutagenicity, or carcinogenicity from spinosad exposure2

Spinosad Topical Suspension 0.9% has also demonstrated similar or lower treatment-related AEs than Nix® (permethrin 1%), the leading OTC medication.6

chart-3
*Statistically significant (3.1% vs. 6.8%; p=0.007)
There is no known resistance to the compound, spinosad, in head lice and cross-resistance with other insecticides has not been reported for spinosad.<sup>7</sup>

There is no known resistance to the compound, spinosad, in head lice and cross-resistance with other insecticides has not been reported for spinosad.7

Important Safety Information

Indication
Spinosad Topical Suspension 0.9% is a pediculicide indicated for the topical treatment of head lice infestations in patients six (6) months of age and older.

Adjunctive Measures
Spinosad Topical Suspension 0.9% should be used in the context of an overall lice management program:
• Wash (in hot water) or dry clean all recently worn clothing, hats, used bedding and towels
• Wash personal care items such as combs, brushes, and hair clips in hot water
• A fine-toothed comb or special nit comb may be used to remove dead lice and nits.

Important Safety Information
Spinosad Topical Suspension 0.9% contains benzyl alcohol and is not recommended for use in neonates and infants below the age of 6 months. Systemic exposure to benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants when administered intravenously. Most common adverse events were: application site redness (3%), eye redness (2%) and application site irritation (1%).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Nix® is a registered trademark of Prestige Consumer Healthcare Inc.

Reference(s)
  1. IQVIA: May 5, 2020
  2. Data on File
  3. Millar, N. S. & Denholm, I. Nicotinic acetylcholine receptors: targets for commercially important insecticides. Invert. Neurosci. 7, 53-66.
  4. CDC-Headlice-Treatment-OTC Medications (8.18.2016). Retrieved from https://www.cdc.gov/parasites/lice/head/treatment.html
  5. Spinosad Topical Suspension 0.9% Prescribing Information
  6. Stough D, Shellabarger S, Quiring J, Gabrielsen A. Efficacy and safety of spinosad and permethrin crème rinses for pediculosis capitis (head lice). Pediatrics. 2009;124(3): e389-395.
  7. Spinosad Technical Bulletin Dow AgroSciences LLC (Now Corteva agriscience), Form No. Y45-000-001 (01/01) CBK.

SPN-RRW8-001

Important Safety Information

Indication
Spinosad Topical Suspension 0.9% is a pediculicide indicated for the topical treatment of head lice infestations in patients six (6) months of age and older.

Adjunctive Measures
Spinosad Topical Suspension 0.9% should be used in the context of an overall lice management program:
• Wash (in hot water) or dry clean all recently worn clothing, hats, used bedding and towels
• Wash personal care items such as combs, brushes, and hair clips in hot water
• A fine-toothed comb or special nit comb may be used to remove dead lice and nits.

Important Safety Information
Spinosad Topical Suspension 0.9% contains benzyl alcohol and is not recommended for use in neonates and infants below the age of 6 months. Systemic exposure to benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants when administered intravenously. Most common adverse events were: application site redness (3%), eye redness (2%) and application site irritation (1%).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.