||August 15, 2011
- Eliminated head lice infestations without nit combing
- Nearly twice as effective at eliminating lice infestations as permethrin 1%, the current market leader
- FDA Approved
Carmel, IN. -Natroba™ (spinosad) Topical Suspension, 0.9% is now available in pharmacies throughout the United States. Natroba™ is an effective, easy-to-use topical suspension, which does not require nit combing.
Natroba™, which eliminates head lice (pediculosis capitis), was approved in January 2011 by the Food and Drug Administration (FDA) as a prescription medication for the topical treatment of head lice infestations in patients four (4) years of age and older.
“Ever since Natroba™ received FDA approval earlier this year, there has been significant interest from parents and health care professionals all across the country who have requested information about product availability,” said Bill Culpepper III, President, ParaPRO LLC. “ We believe that based on the high level of interest, there will be strong demand for this new and effective head lice treatment. We are delighted to announce that Natroba™ is now being shipped to pharmacies around the country, just in time for the back-to-school head lice season. In clinical trials, Natroba™ was shown to be nearly twice as effective as the most commonly prescribed head lice medication, permethrin 1%, and in those trials Natroba™ was proven effective without the need for extensive and time-consuming nit combing sessions.”
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.
Natroba™ (pronounced na-ˈtrōb- ə) treats head lice using spinosad, a compound derived from a naturally occurring soil microbe. Natroba™ is unique because nit combing, which can be painstaking and time consuming, is not required. In clinical trials, Natroba™ was nearly twice as effective at eliminating head lice infestations compared to permethrin 1%. The most common side effects with Natroba™ were application site and eye redness and irritation.
How does Natroba™ work against head lice?
According to the patient instructions, Natroba™ should be applied to dry scalp and hair, left on for 10 minutes, and then rinsed off with warm water. Natroba™ is effective without nit combing.
What are the details of the studies?
The two Phase III studies confirmed the safety of Natroba™ as well as its superior efficacy as compared to permethrin 1%, the most commonly prescribed head lice treatment to date.
This is significant because permethrin is acknowledged within the American Academy of Pediatrics (AAP) guidelines published in 2010 as “the most studied pediculicide in the United States and …the least toxic to humans.” Permethrin (sold under the brand name Nix®) was selected as a comparator because it was the head lice treatment recommended by the American Academy of Pediatrics (AAP) at the time the study protocol was approved by the FDA. The studies were published online in the journal Pediatrics (Pediatrics 2009; 124:e389-e395).
The participants who used Natroba™ at home were instructed to treat for 10 minutes and rinse. They were not provided with a nit comb. Those who were treated with Nix® were provided a comb and instructed to try to remove 100 percent of the nits using the comb.
A total of 84.6% (study 1) and 86.7% (study 2) of Natroba™-treated participants were lice-free compared with 44.9% and 42.9% treated with Nix®. The p value for both studies was <. 001.
Why is it significant that nit combing wasn’t required with Natroba™?
In clinical studies, Natroba™ was proven effective without nit combing. Currently, there are many head lice treatments available over-the-counter and by prescription. The most commonly recommended product by pediatricians requires the removal of nits, usually by combing. If a small number of viable nits remain, re-infestation could occur when the eggs hatch.
What are the possible side effects that could occur with Natroba™?
The most common side effects with Natroba™ clinical studies were application site and eye redness and irritation. Overall there were few adverse events reported in the studies. Redness of the skin occurred in 3% of the Natroba™ patients (vs. 7% of permethrin), redness and irritation of the eyes occurred in 2% of the Natroba™ patients (vs. 3% of permethrin) and application-site irritation 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).
What other important safety information should we know about Natroba™?
Natroba™ 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.
Natroba™ is a prescription, topical treatment for use only on the hair and scalp as directed by a physician. For additional safety information, see the patient and full prescribing information at www.Natroba.com.
Pernix Therapeutics is a co-promotion partner with ParaPRO. Pernix Therapeutics Holdings, Inc. is a specialty pharmaceutical company primarily focused on the sales, marketing, and development of branded and generic pharmaceutical products primarily for the pediatric market. Additional information about Pernix is available at www.pernixtx.com.
Centers for Disease Control and Prevention, available at www.cdc.gov/parasites/lice/head/gen_info/faqs.html
Accessed Aug. 12, 2011.
Wolters Kluwer Health, Source® Pharmaceutical Audit Suite prescription pediculicide/head lice market audit current 12 months, July 2011
- Nix is a registered trademark and the property of its owner.
- Frankowski BL, Weiner LB; American Academy of Pediatrics, Committee on School Health, Committee on
Infectious Diseases, Head Lice, Pediatrics 2002; 110(3):648-643.
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.
West & Company
Ask your doctor if Natroba™ Topical Suspension is right for you or your child.
Natroba™ Topical Suspension is a pediculicide indicated for the topical treatment of head lice infestations in patients
six (6) months of age and older.
Natroba™ 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%), eye redness (2%) and application
site irritation (1%).
Consult the Patient Information, Full Prescribing Information and your doctor for more complete information on Natroba™ Topical Suspension.
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.