LAVAL, Quebec, Jan. 10, 2017 /CNW/ -- Valeant Pharmaceuticals
International, Inc. (NYSE: VRX and TSX: VRX) ("Valeant" or
the "Company") today announced positive results from a second
confirmatory pivotal Phase 3, multicenter double-blind, randomized,
vehicle-controlled clinical study to assess the safety and efficacy
of IDP-118 (halobetasol propionate and tazarotene) lotion in the
treatment of plaque psoriasis.
Within the Phase 3 study of 203 adult subjects with moderate to
severe psoriasis, IDP-118 showed statistical significance (p <
0.001) to vehicle with a treatment success rate at 8 weeks of
35.76% to 6.98%. The primary endpoint of the 12-week study (8
weeks of treatment followed by 4 weeks of follow-up) was
achievement of a "clear" to "almost clear" score and at least a 2
grade improvement based on an Investigator Global Assessment (IGA)
at 8 weeks, and clear to almost clear and at least 2 grade
improvement in the IGA at weeks 12, 6, 4 and 2 as secondary
endpoints.
"Investing in R&D and developing innovative products that
improve people's lives continue to be priorities as we enter 2017,"
stated Joseph C. Papa, Chairman and
Chief Executive Officer. "We are optimistic about the results
of this confirmatory Phase 3 study, which demonstrate that the
novel formulation in IDP-118, with its dual mechanism of action,
can achieve greater efficacy at a much lower concentration while
reducing irritation in patients who use a corticosteroid-retinoid
combination to treat psoriasis."
While halobetasol propionate and tazarotene are both approved
and used to treat plaque psoriasis, each has certain attributes
that can influence the treatment duration owing to potential
adverse events. Based on existing data from our clinical
studies, the combination of these ingredients in IDP-118 with a
dual mechanism of action potentially allows for expanded use of
these active ingredients with reduced adverse events.
On December 8, Valeant announced
the results of a prior Phase 3 study of 215 adult subjects with
moderate to severe psoriasis. In this study, IDP-118 showed
statistical significance (p<0.001) to vehicle with a treatment
success rate at 8 weeks of 45.33% to 12.51%. The primary
endpoint of the 12-week study (8 weeks of treatment with 4 weeks of
follow-up) was achievement of a "clear" to "almost clear" score and
at least 2 grade improvement based on an Investigator Global
Assessment (IGA) at 8 weeks, and achieving clear to almost clear
and at least 2 grade improvement in the IGA at weeks 12, 6, 4 and 2
as secondary endpoints.
The Phase 3 program was preceded by a successful Phase 2 study
where the combination product IDP-118, with a treatment success
rate of 52.5%, was superior to each of the actives halobetasol
propionate and tazarotene as well as the vehicle, which
demonstrates the IDP-118 formulation is superior to using the
individual actives separately.
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, gastrointestinal disorders,
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 which 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, 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. Readers are
cautioned not to place undue reliance on any of these
forward-looking statements. 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, unless required by law.
Contact Information:
Elif McDonald
elif.mcdonald@valeant.com
514-856-3855
877-281-6642 (toll free)
Media:
Renée Soto
or
Chris Kittredge/Jared Levy
Sard Verbinnen & Co.
212-687-8080
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SOURCE Valeant Pharmaceuticals International, Inc.