Carmel, IN. - ParaPRO LLC announced today that two phase 3 clinical trails have begun for its lead investigational product, a crème rinse containing Spinosad, for the treatment of human head lice. The product, tentatively branded NatrOVA™, is being tested in the following 12 regions
- Indianapolis, Indiana
- Central Alabama (Columbiana)
- Tampa Bay, Florida (Largo)
- Metropolitan Cleveland (S. Euclid)
- San Antonio, Texas
- Los Angeles, California (Beverly Hills)
- Central Arkansas (Hot Springs)
- Corpus Christi, Texas
- West Palm Beach, Florida
- Daytona / Orlando, Florida (Ormond Beach)
- Salt Lake City, Utah (Layton)
- Omaha Nebraska / Council Bluffs Iowa
All sites are currently recruiting patients. Contact information for a specific location can be found at www.parapro.com/trialsites.aspx.
“Results from earlier clinical trials have been very encouraging,” said David Rowe, VP Development at ParaPRO. “Our goal now is to evaluate the safety, and efficacy of our product in a larger and more geographically diverse patient population. Results to date suggest that this product might provide significant benefits to parents, children, and health providers.”
Spinosad (pronounced "spin-OH-sid") is derived through the fermentation of a naturally occurring organism. Spinosad has been registered by Dow AgroSciences for crop protection use in more than 30 countries and has been recognized by regulatory agencies such as the U.S. Environmental Protection Agency (EPA) for its efficacy on insect pests, low mammalian toxicity and low environmental impact. In 2002, Spinosad was approved by the National Organics Standards Board for use in the production of “certified organic” foods. ParaPRO licensed the worldwide rights to Spinosad from Eli Lilly and Company in 2002 to develop and market the compound for the control of lice in human health.
Head lice (Pediculosis capitis) infestation is common in the United States among children 3 to 12 years of age. According to the American Academy of Pediatrics approximately 6 to 12 million children have infestations each year. One study estimated that in 1998, 12 to 24 million school days were lost due to lice outbreaks. Estimates for combined direct and indirect costs to control head lice in the United States may be as high as $1 Billion per year.
ParaPRO announced recently that the company had received a $2.1 million grant from the state of Indiana’s 21st Century Research and Technology Fund to partially finance the phase 3 trials. The company hopes to complete the trials and submit a new drug application (NDA) to the FDA in 2008.
ParaPRO LLC was founded in 2002 when SePRO Corporation of Carmel, IN purchased the worldwide rights to develop and market Spinosad for the control of lice in human health from Eli Lilly and Company. The compound is currently in clinical trials at multiple sites across the United States. More information on ParaPRO can be found at www.parapro.com.
SePRO Corporation is recognized as an industry leader in providing the highest level of technical service to customers who operate in specialty markets of the USA. To learn more about SePRO Corporation, its products, services and technologies, call 1-800-419-7779 or visit the SePRO web site at www.sepro.com.
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.