Results Published in the Journal of the American Academy of Dermatology
MONTREAL, Nov. 26, 2012 /CNW/ - Valeant Pharmaceuticals International,
Inc. (NYSE: VRX and TSX: VRX) announced today that the Journal of the American Academy of Dermatology has published the positive results from our two pivotal, international,
multicenter, randomized, double-blind, vehicle-controlled studies that
were conducted in 1,655 subjects with onychomycosis. Onychomycosis is a
common nail infection caused predominantly by dermatophyte fungi,
resulting in nail destruction and deformity. The only approved topical
treatments are lacquers with very limited efficacy. Oral treatments,
while more efficacious, are limited by drug interactions and numerous
safety concerns including the potential for acute liver injury. Valeant
investigated the safety and efficacy of efinaconazole 10% topical
solution (efinaconazole), the first triazole antifungal agent developed
for distal lateral subungual onychomycosis (DLSO).
The study's primary endpoint was stringently defined as the complete
cure rate at Week 52, which means that the target nail showed no
clinical involvement and no evidence of fungus present by both KOH
testing and a negative fungal culture. In Study 1, 17.8% of subjects
treated with efinaconazole were completely cured, as compared to only
3.3% of subjects treated with vehicle and in Study 2, 15.2% of subjects
treated with efinaconazole were completely cured, as compared to only
5.5% of subjects treated with vehicle. Using the secondary endpoint of
complete or almost complete cure, defined as 5% clinical involvement
and 100% mycologic cure, the success rates for efinaconazole increased
to 26.4% and 23.4%, respectively. The adverse events that were reported
were generally mild and transient and were similar between subjects
treated with efinaconazole solution 10% and vehicle.
"We are pleased to share the positive results from the two Phase III
studies of efinaconazole with the publication by a leading dermatology
journal," stated J. Michael Pearson, chairman and chief executive
officer. "While oral treatment of onychomycosis has been the standard
of care, drug interactions and risk of acute liver injury may limit
their use especially in older adults where disease is most prevalent,
those on multiple drug regimens, or for patients or doctors who prefer
topical therapies. As no new onychomycosis treatments have been
introduced for over 10 years, we believe in the authors' conclusion
that this may be the first topical treatment option for DLSO that can
be considered a viable alternative to oral treatments."
"This is a very exciting time for patients with the pending launch of
the first new topical anti-fungal treatment approved in more than a
decade," said Boni Elewski, MD Professor of Dermatology, University of
Alabama. "Onychomycosis is a common infection that, left untreated, can
later appear not only on other toes and fingers, but also on friends
and family, too. It is estimated that one in ten Americans suffer from
onychomycosis, which causes the nail to thicken and can be quite
painful, making this condition more than just a cosmetic problem.
Furthermore, as some research indicates that up to half of patients
over the age of 70 suffer from this progressive disease. An effective
topical therapy like efinaconazole is a logical treatment option to
avoid drug interactions and systemic side effects, as these patients
undoubtedly take other oral medications."
For the complete article, please go to http://www.jaad.org.
The two large, international, multicenter, randomized, double-blind,
vehicle-controlled studies were conducted in subjects with
onychomycosis affecting at least one great toenail. The toenail was
required to have at least 20-50% of clinical involvement. Study 1 had
870 subjects and Study 2 had 785. They were randomized in a 3:1 ratio
to efinaconazole topical solution 10% or to vehicle. Treatment was
applied once-daily for 48 weeks, with post-treatment follow-up
occurring at Week 52. Debridement was not performed in the studies.
The primary endpoint was stringently defined as the complete cure rate
at Week 52, which means that the target nail showed no clinical
involvement and no evidence of fungus present by both KOH testing and
by a negative fungal culture.
In both studies, the primary endpoint of complete cure was statistically
significant (P < .001) in favor of efinaconazole topical solution 10%. In Study 1,
17.8% of subjects treated with efinaconazole were completely cured
compared to only 3.3% of subjects treated with vehicle. In Study 2,
15.2% of subjects treated with efinaconazole were completely cured
compared to only 5.5% of subjects treated with vehicle. Although no
head-to-head studies have been conducted, these results are comparable
to that reported with oral treatment of onychomycosis.
Both studies also found that mycologic cure rates were also
statistically significant (P < .001) in favor of efinaconazole topical solution 10%. In Study 1,
55.2% of subjects treated with efinaconazole demonstrated mycologic
cure compared to only 16.8% of subjects treated with vehicle. In Study
2, 53.4% of subjects treated with efinaconazole demonstrated mycologic
cure compared to only 16.9% of subjects treated with vehicle. Given
that healthy toenails can take 78 weeks to grow completely, it is not
surprising that mycologic cure rates are greater than complete cure
rates. In addition, more patients treated with efinaconazole (Study 1:
26.4% and Study 2: 23.4%) achieved a complete or almost complete cure
(5% clinical involvement and mycologic cure) compared with vehicle
(Study 1: 7.0% and Study 2: 7.5%; both P .001).
The adverse events that were reported were generally mild and transient
and were similar between subjects treated with efinaconazole solution
10% and vehicle. Local site reactions were infrequently reported (e.g.,
dermatitis), and appeared to be more likely to occur with efinaconazole
About Valeant Pharmaceuticals International, Inc.
Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a
multinational specialty pharmaceutical company that develops,
manufactures and markets a broad range of pharmaceutical products
primarily in the areas of neurology, dermatology and branded generics.
More information about Valeant Pharmaceuticals International, Inc. can
be found at www.valeant.com.
About The Journal of the American Academy of Dermatology
As the official publication of the American Academy of Dermatology, the
Journal is dedicated to the clinical and continuing education needs of
the entire dermatologic community and is internationally known as the
leading journal in the field. Original, peer-reviewed articles cover
clinical and investigative studies, treatments, new diagnostic
techniques, and other topics relating to the prevention, diagnosis, and
treatment of disorders of the skin. Included are CME articles based on
the Core Curriculum of the American Academy of Dermatology.
The Journal is ranked 3rd of 43 journals in the Dermatology category in the 2009
Journal Citation Reports®, published by Thomson Reuters, and has an
Impact Factor of 4.081. The Journal of the American Academy of Dermatology is also recommended for purchase in the Brandon-Hill study, Selected
List of Books and Journals for the Small Medical Library.
These forward-looking statements relate to, among other things, the
efficacy of efinaconazole, the approval, if any, of efinaconazole by
FDA or other similar regulatory agencies and the role of efinaconazole
as a treatment for onychomycosis. Forward-looking statements can
generally be identified by the use of words such as "believe,"
"anticipate," "expect," "estimate," "intend," "continue," "plan,"
"project," "will," "may," "should," "could," "would," "target,"
"potential" and other similar expressions. In addition, any statements
that refer to expectations, projections or other characterizations of
future events or circumstances are forward-looking statements. Actual
results may differ materially from those expressed or implied in such
statements. Important factors that could cause actual results to differ
materially from these expectations include, among other things, the
decisions by FDA or other similar regulatory agencies, the efficacy of
efinaconazole and the market acceptance of efinaconazole, and the risk
factors as detailed from time to time in Valeant's reports filed with
the Securities and Exchange Commission and the Canadian Securities
Administrators. Valeant cautions that the foregoing list of important
factors that may affect future results is not exhaustive. When relying
on Valeant's forward-looking statements to make decisions with respect
to Valeant, investors and others should carefully consider the
foregoing factors and other uncertainties and potential events. Valeant
undertakes no obligation to update or revise any forward-looking
statement, except as required by law.
Laurie W. Little
SOURCE: Valeant Pharmaceuticals International, Inc.
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