BRIDGEWATER, N.J., Feb. 7, 2012 /PRNewswire/ -- Sanofi
announced today that the U.S. Food and Drug Administration (FDA)
has approved Sklice® (ivermectin) lotion, 0.5% for the topical
treatment of head lice, in patients 6 months of age and older.
Effective and well-tolerated, Sklice Lotion treats lice in most
patients with a single 10-minute application of the lotion, without
nit combing.
"The approval of Sklice Lotion provides physicians and
parents with a new treatment option for head lice, a condition that
is notoriously frustrating to treat," said Kenneth P. Guito, General Manager, Sanofi-Topaz.
"Through a unique mode of action, Sklice Lotion resolves most
head lice infestations in one application, and is very
well-tolerated."
Sklice will be commercialized by Sanofi Pasteur U.S., an
established leader in the pediatric area with an extensive heritage
of bringing innovative solutions to the pediatric healthcare
community. "We are pleased that Sanofi Pasteur – through
our longstanding relationships with pediatric professionals -- can
help address the burden of head lice by bringing a well-tolerated,
effective, single application treatment option to patients 6 months
and older," added Chad Hoover,
Vice President and Chief Commercial Officer, Sanofi Pasteur
U.S.
Each year in the United States,
head lice infest an estimated 6 to 12 million children aged 3 to 11
years. Estimates for direct and indirect costs, which include
millions of lost school days and lost work for parents, are as high
as 1 billion dollars.
Formulated with ivermectin, an antiparasitic that has been used
orally for more than 20 years and more than 1 billion times to
treat other parasites, Sklice Lotion was developed to meet the
demand for an effective, convenient head lice treatment that works
differently and is well-tolerated in children.
"This single treatment option provides parents with an
additional choice to manage a head lice infestation. Helping
children get back to school and parents back to work is a win-win
situation for all involved," stated Dr. Bill Ryan, BVSc, consultant to Sanofi Pasteur
U.S., who led the clinical trial programs for Sklice Lotion.
The FDA approval of Sklice Lotion was based on results of two
randomized, double-blind phase 3 clinical trials that compared
Sklice Lotion with a vehicle control (placebo) in 781 patients from
the United States who were 6
months of age and older. Significantly more subjects in the Sklice
Lotion group were louse-free, Sklice was well-tolerated and the
majority of Sklice-treated patients were lice-free without any nit
combing after two weeks. Fewer than 1% of patients experienced
adverse events, which included conjunctivitis, ocular hyperemia,
eye irritation, dandruff, dry skin and skin-burning sensation.
About Head Lice
Head lice are wingless, parasites that feed on human blood and
live close to the human scalp. They move by crawling and are mainly
spread by head-to-head contact, most commonly among preschool
children attending child care, elementary schoolchildren and the
household members of infested children. Infrequently, transmission
may occur by contact with items recently used by an infested
person, such as clothing, brushes, towels or pillows.
Although head lice infestation is not related to cleanliness,
patients experience social stigma, embarrassment and low
self-esteem. The process of eradicating lice and their nits can be
stressful, tedious and costly.
About Sklice Lotion
Sklice Lotion contains a broad-spectrum antiparasitic agent,
ivermectin, which was developed from a soil bacterium that produces
a family of compounds (avermectins) shown to bind selectively and
with high affinity to certain ion channels present in invertebrate
nerve and muscle cells but not in mammals. The resulting increased
permeability of the cell membrane causes paralysis and death in
certain parasites.
Widespread oral use of ivermectin began in 1987 to control river
blindness (onchocerciasis) in humans. More than one billion
treatments of ivermectin tablets have been administered to help
alleviate the suffering caused by river blindness and other
parasitic conditions.
Sklice Lotion was developed by Topaz Pharmaceuticals, which was
acquired by Sanofi Pasteur in October, 2011.
Sklice Lotion Pivotal Trials
The FDA submission for Sklice Lotion included two identical
multi-center, randomized, double-blind, vehicle-controlled studies
conducted in subjects 6 months of age and older with head lice
infestation. Sklice Lotion or placebo was dispensed to all subjects
for application to dry hair and scalp followed by a rinsing after
10 minutes, with instructions not to use a nit comb. For the
evaluation of efficacy, the youngest subject from each household
was considered to be the index subject of the household (n=289).
Other enrolled infested household members received the same
treatment as the youngest subject. Subjects were also evaluated for
safety and local tolerability.
The primary efficacy was assessed as the proportion of index
subjects who were free of live lice at day 2 and through day 8 to
the final evaluation 14 (+2) days following a single application.
The secondary efficacy endpoint was the same assessment applied to
the other enrolled subjects. Those with live lice present at any
time up to the final evaluation were considered treatment
failures.
Important Safety Information
No adverse events occurred at a rate greater than or equal to 1%
in placebo-controlled trials using a single 10-minute treatment of
Sklice Lotion in 379 patients ages 6 months and older. The most
common adverse reactions (incidence
