Formulated with PRISMATREX™, a proprietary
technology, DUOBRII™ lotion improves the signs and symptoms of
plaque psoriasis in adult patients with moderate to severe plaque
psoriasis.
LAVAL, QC, Sept. 2, 2020 /CNW Telbec/ - Bausch
Health, Canada, part of Bausch Health Companies Inc. (NYSE:
BHC) (TSX: BHC), ("Bausch Health" or the "Company") today
announced that its novel topical prescription drug for improving
the signs and symptoms of plaque psoriasis in adult patients is now
available in Canada.
DUOBRII™ (0.01% w/w halobetasol propionate and 0.045% w/w
tazarotene) is indicated for adults with moderate to severe plaque
psoriasis.i The product is manufactured for distribution
throughout Canada and the United States at the Company's
Quebec manufacturing facility in Laval.
"Achieving clear skin is the primary goal of patients, and this
is equally so for the physicians who treat them," says Richard Lajoie, President and General Manager,
Bausch Health, Canada. "As a company fully committed to the
Canadian psoriasis community, we are sensitive to the challenges
faced in improving the quality of life of patients with psoriasis.
DUOBRII works in a unique way by combining halobetasol propionate,
which reduces inflammation; and tazarotene that contributes to the
normalization of skin cell growth. We are excited to bring this
novel product to Canadians and very proud that it is being
manufactured at our own facility here in Canada."
Dr. Neil H. Shear, MD, FRCPC, Professor and Head of
Dermatology, Sunnybrook Health Sciences Centre has spent decades
treating psoriasis patients. "Offering my patients a new option
with promising, long-term results will help deliver what every
psoriasis patient hopes for: achieving clear skin. Psoriasis is a
chronic condition, which means that patients need continuous
solutions to manage their symptoms. With DUOBRII, we are seeing
positive results in as little as two weeks, which is highly
encouraging. The fact that it is the only Health Canada-approved
drug for psoriasis to provide extended clearance post-treatment is
an important benefit."
Psoriasis is a common, chronic, and life-altering skin condition
that affects approximately one million Canadians, with 90% of those
affected suffering from plaque psoriasis.ii
The disease is characterized by red elevated patches and flaking
silvery scales, and symptoms can range from mild to severe. While
the psoriatic lesions can appear anywhere on the body, the most
common places include the elbows, knees, scalp, chest and lower
back. Because the disease typically affects visible parts of the
body, the impact on patients extends well beyond the physical
symptoms. Psoriasis often impacts nearly every aspect of an
individual's life including their ability to work and maintain
social and intimate relationships. In addition to the tremendous
medical burden experienced while trying to find a medication that
controls the disease, the psychological impact is high. Many
individuals suffer from low self-confidence, anxiety, depression
and sleep deprivation.iii
"We know how difficult psoriasis is to treat and it is even
harder to live with for patients and their families," said
Rachael Manion, Executive Director
of the Canadian Association of Psoriasis Patients (CAPP). "Patients
deserve the most advanced and effective treatment options
available, and we are encouraged that Bausch Health, Canada has brought DUOBRII to market as a new
topical treatment option for patients with moderate to severe
psoriasis."
DUOBRII lotion provides the combined action of two unrelated
compounds, halobetasol propionate, a corticosteroid, and
tazarotene, a retinoid prodrug. These well-known ingredients have
long-established efficacy profiles. When halobetasol propionate and
tazarotene are administered together in DUOBRII, they provide
complementary effects due to their individual modes of action
targeting different receptors and pathways to achieve
anti-inflammatory control and epidermal morphologic restoration.
The improvement that is seen in psoriatic patients appears to occur
in association with the restoration of normal cutaneous morphology
and the reduction of the inflammatory markers ICAM-1 and
HLA-DR.iv
DUOBRII is also distinct based on its Prismatrex™ technology, a
polymeric emulsification system which provides a stable condition
where emulsion droplets retained their distribution across time and
temperature.v
The clinical efficacy and safety of once daily use of DUOBRII
were assessed in two prospective, multi-centre, randomized,
double-blind Phase III clinical trials in subjects 18 years and
older with moderate to severe plaque psoriasis. In the Phase III
pivotal studies, analysis of the primary efficacy endpoint
demonstrated that Duobrii was statistically significantly more
effective than Vehicle Lotion in achieving treatment success in the
Investigator's Global Assessment (IGA) at Week 8, defined as at
least a 2-grade improvement from Baseline and a score of Clear or
Almost Clear in both studies.vi
In the first study 35.76% of subjects in the DUOBRII group had
treatment success at Week 8 compared with 6.98% in the Vehicle
group. In the second study, 45.33% of the subjects in the Duobrii
group had treatment success at Week 8 compared with 12.51% in the
Vehicle group.vi In the clinical studies, the individual
signs of psoriasis (erythema, plaque elevation, and scaling) showed
sustained efficacy improvement up to 4 weeks after
treatment.vii
While the exact cause of psoriasis has not yet been determined,
researchers believe it involves a combination of genetic,
environmental, and immune factors. Psoriasis develops when there is
a malfunctioning of the immune system which causes inflammation.
White blood cells (T cells) in the immune system are triggered and
this causes inflammation to occur, which then causes skin cells to
rise to the surface and shed at 10 times the normal rate.
About Bausch Health Companies Inc.
Bausch Health
Companies Inc. (NYSE/TSX: BHC) is a global company whose
mission is to improve people's lives with our health care products.
We develop, manufacture and market a range of pharmaceutical,
medical device and over-the-counter products, primarily in the
therapeutic areas of eye health, gastroenterology, and dermatology.
We are delivering on our commitments as we build an innovative
company dedicated to advancing global health.
In Canada, the Company's prescription product portfolio is
focused on eye health, dermatology, and cardio-metabolic
conditions. More information can be found on the Company's website
at bauschhealth.ca.
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i DUOBRII Product
Monograph. Bausch Health, Canada Inc. June 16,
2020 p.3
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ii https://www.canadianpsoriasisnetwork.com/psoriasis/forms-of-psoriasis/
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iii https://www.canadianpsoriasisnetwork.com/wp-content/uploads/2020/06/Fact_Sheet_Rheumatologists_Psoriasis_Journey_to_Stability_8-5x11_EN_x1a_bleed.pdf
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iv DUOBRII Product
Monograph. Bausch Health, Canada Inc. June 16,
2020 p.13
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v Data in Health Canada NDS
submission
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vi DUOBRII Product
Monograph. Bausch Health, Canada Inc. June 16,
2020 p.18
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vii DUOBRII Product
Monograph. Bausch Health, Canada Inc. June 16,
2020 p.19
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SOURCE Bausch Health