Insecticide-Free Head Lice Treatment Enters Phase III Clinical Trials
Insecticide-Free Head Lice Treatment Enters Phase III Clinical Trials
Promising Treatment for Pediculosis to Enter Phase III Clinical Trials
GREENSBORO, N.C., March 17, 2006 -- Piedmont Pharmaceuticals today announced it received confirmation from the U.S. Food and Drug Administration (FDA) to begin Phase III clinical trials with its Resultz patented pediculicide rinse. In a February 27 meeting with Piedmont Pharmaceuticals' representatives, the FDA confirmed that its Center for Drug Evaluation and Research had reviewed the safety and efficacy data from the Company's pre-clinical research and Phase II clinical trials. The agency found Resultz qualified to move forward with Phase III trial protocols.
Already having successfully launched the technology last year in the United Kingdom and Ireland with a European marketing partner, Piedmont is now exploring a range of marketing and out-licensing opportunities for North and South America, the remainder of Europe and the Pacific Rim. The new treatment is expected to receive Canadian regulatory clearance shortly.
In contrast to current treatments which contain insecticides such as lindane, malathion, permethrin and pyrethrins that are neurotoxic to insects, Piedmont's patented treatment utilizes an insecticide-free, non-neurotoxic formulation. The treatment is colorless, odorless, and does not require the use of a special lice comb.
Using a novel patented formulation developed internally by the Company's scientists, the drug works by quickly dissolving the wax that covers the exoskeleton of insects, resulting in the dehydration and subsequent death of the lice. Piedmont is optimistic that the successful completion of Phase III trials and approval for marketing would place its treatment as the first and only one with this mode of action to go through the FDA's approval process.
"Most importantly," says Dr. Kathy Palma, an entomologist and senior scientist at Piedmont, "thanks to our formulation's mechanical-rather than chemical-mode of action, lice are highly unlikely to develop resistance to it."
Head lice resistant to current treatments; overuse raises safety concerns A study published in The Archives of Dermatology noted that head lice resistance to current treatments is increasing in the U.S., and there is an "urgent need for lice treatments...that incorporate a resistance prevention strategy." Numerous reports document that head lice have developed resistance to the insecticides in current treatments, including lindane, malathion and permethrin. (Arch Dermatol. 2003;139:1061-1064, Arch Dermatol. 2002;138:220-224, Arch Ped Adol Med. 1999;153:969-973, Amer Jnl Mgd Care. 2002;9SUP:S269-272) The resistance problem manifests itself in lack of efficacy and has created overuse/misuse of current treatments, raising safety concerns.
Head lice are ectoparasites that survive by sucking blood from the host's scalp, causing irritation, itching and sores. According to the Centers for Disease Control and Prevention (CDC), head lice infestation (Pediculosis humanus capitis) is common around the world, found primarily among young schoolchildren from 3-10 years of age. The parasites affect all socioeconomic groups, and there are an estimated 6 to 12 million cases of lice each year in the U.S. alone.
Lice are so prevalent in young schoolchildren that most U.S. schools have an official lice policy. Such policies usually require that children with lice be sent home until they are lice-free. The social stigma associated with having head lice can be traumatic and schools report severe educational setbacks for students who miss numerous days. The American Academy of Pediatrics and the National Association of School Nurses say no healthy child should be excluded from school due to head lice. (Ped 2002;110:638-643)
The social, economic and educational impact is considerable. In the U.S., total direct costs for treatment and indirect costs for lost wages, educational programs and school and nursing home monitoring programs have been estimated at more than $1 billion annually. (Clin Pediatr 2004;43:323)
For more information, please visit Piedmont Pharmaceuticals
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