ParaPRO: Innovations in Life Sciences

ParaPRO Press Release

Date: May 10, 2011 Back

New Study in the Journal PediatricsĀ® Reports Results Showing Superior Efficacy of Spinosad Head Lice Treatment as Compared to Permethrin

  • Products compared in actual use conditions
  • Spinosad suspension shown effective in first treatment and without nit combing

Carmel, IN. -ParaPRO, LLC announced today that the Therapeutics Subcommittee of the Indiana Medicaid Drug Utilization Review Board has voted to recommend Natroba™ (spinosad) Topical Suspension, 0.9% for its Preferred Drug List (PDL).   Natroba™ is an effective, easy-to-use topical solution, resolving most head lice problems with just one 10-minute application and no nit combing.

Natroba™, which eliminates head lice (pediculosis capitis), was approved in January 2011 by the Food and Drug Administration (FDA) and will be available by prescription this summer for patients four (4) years of age and older.

“The Therapeutics Subcommittee is to be commended for its thorough review of the safety and efficacy data supporting the use of Natroba™ for the treatment of head lice infestations,” said Bill Culpepper III, president of ParaPRO, LLC. “These data were derived from two Phase III clinical trials conducted in multiple sites across the U.S, including Indiana.  The studies were funded in part by a grant from Indiana’s 21st Century Fund, which is led by the Indiana Economic Development Corporation (IEDC).  The IEDC grant made it possible for ParaPRO to conduct these large scale studies simultaneously and those studies supported FDA’s approval of Natroba earlier this year.”

The Therapeutics Subcommittee recommended that Natroba be available to health care professionals to prescribe for their state Medicaid patients without prior authorization.  Last month, the Ohio Pharmacy and Therapeutics Committee made a similar recommendation for Ohio’s Preferred Drug List.

Natroba™ (pronounced na-ˈtrōb- ə) treats head lice using spinosad, a compound derived from a soil microbe.  Natroba™ is unique from the most commonly prescribed head lice treatment in that nit combing, which can be painstaking and time consuming, is not required.   Further, in the clinical studies, patients treated with permethrin 1%, (marketed under the brand name Nix®) more often required an additional round of treatment than patients who were treated with Natroba™.

Head lice are the second most communicable disease among schoolchildren, after the common cold. The U.S. Centers for Disease Control and Prevention estimate that there are between 6 to 12 million cases of head lice infestations each year, mostly in children 3 to 12 years old. Head lice are tiny, wingless insects that live on the human scalp and spread between people by head-to-head contact or the sharing of hats, combs, brushes or towels.

Costs associated with head lice infestations are estimated to be as high as $1 billion per year in the United States alone. Direct costs include treatments and clinic visits, while indirect costs range from school nurse time to school absenteeism to lost wages.

Clinical Studies

Natroba™ is the only head lice treatment whose approval was supported by superiority studies versus permethrin 1%, the most commonly prescribed head lice treatment to date. In two Phase III clinical studies, Natroba™ was significantly more effective in eliminating head lice than permethrin 1% (marketed under the brand name Nix®) – the head lice treatment recommended by the American Academy of Pediatrics at the time the study protocol was approved by the FDA. The studies, published online in the journal Pediatrics (Pediatrics 2009; 124:e389-e395), also confirmed the safety and effectiveness of Natroba™. The 1,038 participants with active head lice infestations were provided either Natroba™ or Nix® to be used at home.  A total of 84.6% (study 1) and 86.7% (study 2) of Natroba™-treated participants were assessed to be lice-free 14 days after the last treatment, compared with 44.9% and 42.9% treated with permethrin (P < 0.001 for both studies). Most participants in the Natroba™ groups (63.8% and 86.2%) needed only one application, whereas most participants in the permethrin groups (60.3% and 64.5%) required two applications. 

There were few adverse events reported in the Phase III clinical studies.  The most commonly occurring adverse events included application-site erythema (redness of the skin), which occurred in 3% of the Natroba™ patients (vs. 7% of permethrin), ocular hyperemia (redness and irritation of the eyes) which occurred in 2% of the Natroba™ patients (vs. 3% of permethrin) and application-site irritation, which occurred in 1% of Natroba™ patients (vs. 2% permethrin).   Although adverse event rates were low for both products, application site redness occurred significantly less frequently in patients treated with Natroba™ than in patients treated with permethrin (P = 0.007).

About ParaPRO
ParaPRO, LLC (www.parapro.com), based in the Indianapolis, Indiana metropolitan area, is a specialty pharmaceutical company focused on commercializing proprietary products for the pediatric market.  ParaPRO is a wholly owned subsidiary of SePRO Corporation (www.sepro.com).

Natroba™ is a trademark of ParaPRO, LLC. Other trademarks are the property of their respective owners.

Nix is a registered trademark and the property of its owner.

Mayo Clinic website, available at http://www.mayoclinic.com/health/head-lice/DS00953. Accessed Dec. 13.2010

Centers for Disease Control and Prevention, available at http://www.cdc.gov/lice/head/factsheet.html. Accessed Sept. 28, 2010.

Lebwohl M, Clark L, Levitt J. Therapy for head lice based on life cycle, resistance and safety considerations. Pediatrics 2007; 119(5): 965-974

Frankowski BL, Weiner LB; American Academy of Pediatrics, Committee on School Health, Committee on Infectious Diseases, Head Lice, Pediatrics 2002; 110(3):648-643.




Ask your doctor if Natroba Topical Suspension is right for you or your child.

INDICATION
Natroba Topical Suspension is a pediculicide indicated for the topical treatment of head lice infestations in patients four (4) years of age and older.

ADJUNCTIVE MEASURES
Natroba TM Topical Suspension 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
Natroba Topical Suspension 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.

Most common adverse events were: application site redness (3%), redness and irritation of the eyes (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.