LAVAL, Quebec, Nov. 25, 2014 /CNW/ -- Valeant
Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX)
announced today that it has received approval from the Food and
Drug Administration (FDA) for ONEXTON™ Gel (clindamycin phosphate
and benzoyl peroxide), 1.2%/3.75%, for the once-daily treatment of
comedonal (non-inflammatory) and inflammatory acne in patients 12
and older. Acne vulgaris is a common skin disorder that affects 40
to 50 million people in the United
States.
"We are very pleased that the FDA has approved this new dual
action medication that gives physicians and patients a new option
for the topical treatment of acne vulgaris," said J. Michael Pearson, chairman and chief executive
officer. "ONEXTON is the fourth product to be approved in our
medical dermatology business in the past twelve months, three of
which were conceived and developed entirely by Valeant's internal
R&D team. This continues to validate our output driven approach
to R&D. Valeant has already successfully launched Jublia®
(efinaconazole) 10%, Retin-A® Micro (tretinoin gel) microsphere
0.08% and Luzu (luliconazole) 1% and we plan to launch ONEXTON™ in
early 2015."
"Acne is a pervasive disease that, if left unchecked, can have
significant impact for patients" said Joshua Zeichner, MD and Director of Cosmetic and
Clinical Research, Department of Dermatology, Mount Sinai Hospital.
"We encourage people with acne to visit a dermatologist or other
healthcare professional for treatment. ONEXTON™ Gel is an effective
topical medication, appropriate for patients with a wide range of
acne and has a favorable tolerability profile."
Information about ONEXTON™ Gel, 1.2%/3.75%
ONEXTON™ Gel is the first and only FDA-approved fixed
combination 1.2% clindamycin phosphate and 3.75% benzoyl peroxide
medication for the once-daily treatment of comedonal
(non-inflammatory) and inflammatory acne. ONEXTON™ Gel has a
favorable cutaneous tolerability profile and contains no
surfactants, alcohol or preservatives. ONEXTON™ Gel has been
studied extensively prior to its approval. In a pivotal trial with
498 patients with moderate to severe acne, efficacy was assessed at
week 12. ONEXTON™ Gel reduced non-inflammatory lesions by a mean of
52% vs. 28% vehicle, for mean absolute reductions of 19 vs. 10,
respectively. ONEXTON™ Gel also reduced inflammatory lesions by a
mean of 60% vs. 31% vehicle, for mean absolute reduction of 16 vs.
8, respectively. In addition, the proportion of patients
experiencing treatment success in the ONEXTON™ group was twice that
of vehicle (35% vs. 17%). Treatment success was defined as at least
2 grade improvement in the Evaluator Global Severity (EGS) score
from baseline.
In the controlled clinical trial, less than 1% of patients
experienced a treatment related adverse event. The most common
treatment-emergent and treatment-related adverse events were:
burning sensation (0.4%), dermatitis contact (0.4%), pruritus
(0.4%) and rash (0.4%). No ONEXTON™ patient had their treatment
discontinued due to any adverse event.
Serious side effects, including inflammation of the colon
(colitis) and allergic reactions have been reported with the use of
combination clindamycin/benzoyl peroxide products. Stop using
ONEXTON™ Gel and contact your doctor right away if you have severe
watery or bloody diarrhea, or if you experience severe itching;
swelling of your face, eyes, lips, tongue or throat; or difficulty
breathing.
About Valeant
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 dermatology, eye health, neurology and
branded generics. More information about Valeant can be found at
www.valeant.com.
Forward-looking Statements
This press release may contain forward-looking statements,
including, but not limited to, the launch of ONEXTON™ Gel
(clindamycin phosphate and benzoyl peroxide), 1.2%/3.75% in early
2015. Forward-looking statements may generally be identified
by the use of the words "anticipates," "expects," "intends,"
"plans," "should," "could," "would," "may," "will," "believes,"
"estimates," "potential," "target" or "continue" and variations or
similar expressions. These statements are based upon the current
expectations and beliefs of management and are subject to certain
risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements.
These risks and uncertainties include, but are not limited to, the
risks and uncertainties discussed in the Company's most recent
annual or quarterly report and detailed from time to time in
Valeant's other filings with the Securities and Exchange Commission
and the Canadian Securities Administrators, which factors are
incorporated herein by reference. These forward-looking statements
speak only as of the date hereof. Valeant undertakes no
obligation to update any of these forward-looking statements to
reflect events or circumstances after the date of this press
release or to reflect actual outcomes, except as required by
law.
Contact Information:
Laurie W.
Little
949-461-6002
laurie.little@valeant.com
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SOURCE Valeant Pharmaceuticals International, Inc.