Le Lézard
Classified in: Health
Subjects: PDT, TRI, FDA

FDA Clears Pesticide-Free Resultz® Lice & Egg Elimination Kit



GREENSBORO, N.C., July 11, 2017 /PRNewswire/ -- Piedmont Pharmaceuticals announces it has received clearance from the U.S. Food and Drug Administration for its patented, pesticide-free RESULTZ® Lice & Egg Elimination Kit, an odorless product that kills and removes head lice and requires only a 5-minute application time. Already a top seller in multiple countries, the RESULTZ Kit is ready to enter the U.S. marketplace, where sales of head lice treatments exceed $250 million. Based on its track record in other countries, this proven, pesticide-free head lice product is expected to be a game changer in the U.S. Piedmont is exploring various strategic options for the RESULTZ Kit, including working with a commercial partner, and has retained Stifel, Nicolaus & Company, Incorporated to serve as its financial adviser.

RESULTZ® Pesticide-Free Lice & Egg Elimination Kit, newly cleared by FDA for use in the U.S., requires just 5 minutes to work, the shortest time for lice products.

Proven in clinical trials, plus real-world use with millions
Clinical studies using the RESULTZ technology have been conducted with more than 1,000 enrolled participants of varying ages. In addition, post marketing safety data have been recorded for many years from Canadian and European partner sales.

Marketed as early as 2005 in 11 countries under RESULTZ and other brand names, Piedmont's invention quickly became a top seller when it was introduced, and has become one of the world's most successful pesticide-free head lice products.  It has been used on millions of patients in these 11 countries, demonstrating its safety and effectiveness in real-world use.

The new U.S. kit, which includes an easy-to-apply liquid and a comb, is recommended for adults and children ages 2 and older, and requires just 5 minutes to work, the shortest time for lice products.

Demonstrated efficacy against "super lice"
In recent years, genetic testing of head lice has shown that lice have developed resistance to the pesticides used in many traditional treatments.  In particular, products containing pyrethroids are becoming less effective.  According to a study published in the Journal of Medical Entomology in March 2016, lice in at least 42 U.S. states have shown genetic resistance to traditional treatments.[i]   

These insecticide-resistant lice have been branded "super lice" in popular culture. The RESULTZ Kit is proven to kill even these resistant lice, and its unique patented formulation eliminates the potential for resistance.

"If you use insecticide-based lice treatments repeatedly, insects will develop mutations that give them genetic resistance or protection from the chemicals. That's what's happened with pyrethroids used in many of the traditional products on the market," says lice expert John Marshall Clark, Ph.D.  Clark directs the Massachusetts Pesticide Analysis Laboratory and is a professor of environmental toxicology and chemistry at the University of Massachusetts Amherst.

"Head lice don't transmit disease; however, they are a global problem, causing itching and scratching and requiring considerable time and effort to eradicate," says Eric Barnett, M.D., Piedmont's executive vice president of business development. "Of concern is the potential misuse of pesticide products on children. When traditional products don't work, consumers may apply them in higher doses or more frequently than labeled. That overuse is worrisome because the products have been evaluated for safety in children when used as directed."

Expected game changer for U.S. marketplace
"I predict the U.S. head lice market will now significantly change," says Nick Thompson, former head of OTC marketing for Piedmont's largest international partner. "Within five years of the launch of Piedmont's innovative non-pesticide product, which is still a category leader in the U.K. and elsewhere, traditional pesticide products virtually disappeared from the UK marketplace. I anticipate a similar chain of events in the U.S."

For more information visit www.ResultzLice.com.

About Piedmont Pharmaceuticals
Piedmont Pharmaceuticals LLC is a Greensboro, N.C.-based strategic pharmaceutical development and licensing company focused on human health therapeutics. The company discovers, develops, and achieves regulatory approval for innovative products and then licenses or sells them to strong commercial partners.  Piedmont team members have extensive experience and success in developing animal health products driven by superior convenience. Piedmont's veterinary business is operated separately as Piedmont Animal Health

[i] Gellatly KJ, Krim S, Palenchar DJ, et.al. Expansion of the Knockdown Resistance Frequency Map for Human Head Lice (Phthiraptera: Pediculidae) in the United States Using Quantitative Sequencing. J Med Entomol. 2016;53(3): 653-659.

Contact:  Alice Coram, 919.293.0243, ext. 201, acoram@visionairemarketing.com

SOURCE Piedmont Pharmaceuticals LLC


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