ParaPRO: Innovations in Life Sciences

ParaPRO Press Release

Date: October 17, 2011 Back

Multi-center Clinical Trial Shows ParaPRO’s Spinosad Eradicates Head Lice and Nits 
Data presented at American Academy of Pediatrics National Conference and Exhibition

Carmel, IN. - ParaPRO, LLC, announced that researchers have presented data showing the effectiveness of Natroba™ (spinosad) Topical Suspension, 0.9% against head lice and nits following one treatment without  nit combing. Those data about the pediculicide, derived from a naturally-occurring soil bacterium, were presented in a poster session on Saturday, Oct. 15, 2011 at the American Academy of Pediatrics (AAP) National Conference and Exhibition (NCE) in Boston.

“The results build upon earlier research indicating spinosad, without nit combing, kills both live lice and nits after treatment, “said Nicole Rogers, MD. “This study also supports previous in vitro findings showing spinosad was ovicidal.”

In the multi-center randomized investigator-blinded clinical dose-ranging trial, 122 patients, ages 2 to 60 years old with active lice infestations, were randomized to receive spinosad or placebo. Efficacy was assessed as the proportion of subjects who were free of live lice and/or viable nits 7 and 14 days after treatment. A single treatment was applied by a study technician to dry hair and scalp for 10 minutes and then rinsed with warm water. All patients were treated without nit combing. On day 7, 92% (33/36) of the spinosad patients were lice free compared to 49% (21/43) of patients treated with placebo (P<0.0001). On day 14, the efficacy rate for the spinosad group was 86% (31/36) compared to 26% for patients treated with placebo (11/43) (P<0.0001). Re-infestation rates between day 7 and 14 (whether as a result of nits hatching or through transmission) were 6% (2/32) for the spinosad group and 50% for the placebo group (10/20). On days 7 and 14, hair and nit samples were collected from patients treated with spinosad and evaluated for ten days following the initial treatment. Investigators determined that nits contained on the hair samples did not hatch after treatment with spinosad.

Patients were asked about any changes in their health or medications. Adverse events were recorded based on the answers provided. Investigators also documented the degree of scalp irritation in patients. There were no severe adverse events reported and no significant differences in adverse events between the spinosad and placebo treated patients.

About Spinosad
Spinosad 0.9% is the active ingredient in Natroba™ (spinosad) Topical Suspension, 0.9%.  Natroba™ is a pediculicide approved by the FDA in January 2011 for the topical treatment of head lice infestations in patients four (4) years of age and older. Two phase III clinical trials were conducted to support the approval of Natroba™. In those trials efficacy was assessed as the proportion of primary subjects who were free of live lice 14 days after final treatment with the product. Patients were assessed at Day 7 and 14 and patients with live lice present on Day 7 received a second treatment. In those Phase 3 studies, 84.6% and 86.7% of patients treated with Natroba™ were free of head lice 14 days after final treatment. The most common adverse events were application site erythema (3%), ocular erythema (2%) and application site irritation (1%).

About Pernix
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.

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.

Contact:
Debbie Davis
West & Company
317.595.0820 (o)
317.508.2179 (c)
debbie@westpr.net




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 six (6) months of age and older.

ADJUNCTIVE MEASURES
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.