New treatment from Bausch Health, Canada indicated to treat seasonal allergy and
associated ocular symptoms in adults, adolescents and children 6
years and older
LAVAL,
QC, May 3, 2023 /CNW/ - Bausch Health
Companies Inc. (NYSE: BHC) (TSX: BHC) is pleased to announce the
availability across Canada of its
new prescription treatment RYALTRIS® (olopatadine
hydrochloride and mometasone furoate nasal spray).
RYALTRIS has been approved by Health Canada for the symptomatic
treatment of moderate to severe seasonal allergic rhinitis (SAR)
and associated ocular symptoms in adults, adolescents, and children
aged 6 years and older.1
"Bausch Health is very pleased that we are now able to make
RYALTRIS available to Canadians, providing an innovative new
combination nasal spray treatment for SAR, which impacts the lives
of the over 9 million Canadians who suffer from SAR or seasonal
allergies often referred to as hay fever,2" said
Cees Heiman, Senior Vice-President,
Europe and Canada, Bausch Health. "The launch of this new
therapy adds to our broad portfolio of treatments that further
establishes Bausch Health as a trusted partner in the healthcare of
Canadians."
"Allergic rhinitis is a common disorder that often doesn't
respond adequately to usual treatments" said Dr. Paul
Keith, Professor, Division of Clinical Immunology and Allergy,
Department of Medicine, McMaster
University. "Nasal congestion, nasal itch, runny nose and
sneezing are classic symptoms of the disorder. Having a treatment,
like RYALTRIS, that provides both a quick onset of symptomatic
relief as well as an anti- inflammatory effect for moderate to
severe seasonal allergic rhinitis and the associated ocular
symptoms can really improve health outcomes and quality of
life in adults, adolescents, and children aged 6 years and
older."
RYALTRIS is a fixed-dose combination therapy that combines two
best-in-class anti-allergy products – the corticosteroid mometasone
and the antihistamine olopatadine3 – to give rapid and
sustained relief from the symptoms of SAR, both nasal and ocular,
in one easy-to-use nasal spray at a competitive price. The onset of
action for nasal symptom relief occurs within 15 minutes after
administration of RYALTRIS.1
About RYALTRIS®
The efficacy and safety of RYALTRIS® were established
in a clinical studies program conducted by Glenmark Pharmaceuticals
Ltd., its developers, in over 4300 healthy and allergic rhinitis
patients with SAR. Twice-daily RYALTRIS provided statistically
significant improvement in both nasal and ocular symptoms vs.
placebo, as well as statistically significant onset of action
in nasal symptom relief vs. placebo at 15 minutes, across three
randomized, double-blind phase 3 studies (P<0.05). The safety
profile of RYALTRIS is typical of that observed with intranasal
drugs of the same classes.1
Important Safety Information for Ryaltris®
RYALTRIS® is an intra-nasal spray and should not
be administered orally, instilled in the eyes, ears or applied to
the skin. In 14-day clinical studies of patients with SAR
taking RYALTRIS twice a day, the most common adverse events
observed were altered taste (3%), nose bleeds (1%) and nasal
discomfort (1%). RYALTRIS should not be used by anyone who has had
an allergic reaction to olopatadine or mometasone or to any
ingredient in the formulation or have untreated fungal, bacterial,
or tuberculosis infections of the respiratory tract. Close medical
supervision is required in anyone who has a weakened immune system,
including those who have had infections with opportunistic
pathogens. Increased risk of occurrence or potential worsening of
pre-existing infections (e.g., tuberculosis) with fungi, bacteria
or viruses can occur, including fatal chickenpox, measles and
herpes infections in susceptible patients. RYALTRIS should be used
under close medical supervision in anyone who has had nose bleeds
or nasal perforation. Recurrence, worsening or persistence of these
nasal problems can occur. The effect of RYALTRIS on pregnancy and
through transmission in breast milk is not known. Talk to your
doctor if you are pregnant, plan to become pregnant or
breastfeeding, to ensure it is safe for you to use.1
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global
diversified pharmaceutical company whose mission is to improve
people's lives with our health care products. We develop,
manufacture and market a range of products primarily in
gastroenterology, hepatology, neurology, dermatology, international
pharmaceuticals and eye health, through our controlling
interest in Bausch + Lomb. With our leading durable brands, we are
delivering on our commitments as we build an innovative company
dedicated to advancing global health. For more information,
visit www.bauschhealth.com and connect with us
on Twitter and LinkedIn.
Bausch Health, Canada Inc.'s prescription treatment
portfolio is focused on dermatology, gastrointestinal and
cardio-metabolic conditions. Bausch Health also has two
manufacturing facilities for prescription pharmaceuticals in
Canada, in Laval, Quebec, and Steinbach, Manitoba. More information can be
found at the Company's website
at www.bauschhealth.ca.
About Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is
an innovation–driven, global pharmaceutical company with a presence
across Branded, Generics, and OTC segments; with a focus on
therapeutic areas of respiratory, dermatology and oncology. The
company has 10 world–class manufacturing facilities spread across 4
continents, and operations in over 80 countries. In Vivo/Scrip 100
positions Glenmark amongst the Top 100 Companies Ranked by R&D
and Pharmaceutical Sales, 2021; while Generics Bulletin/In Vivo
places it in the Top 50 Generics and Biosimilars Companies Ranked
by Sales, 2021. The company has been Great Place To Work®
Certified™ in India, in 2023.
Glenmark has impacted over 2.6 million lives over the last decade
through its CSR interventions. For more information, visit
www.glenmarkpharma.com. Follow us on LinkedIn (Glenmark
Pharmaceuticals) and Instagram (glenmark_pharma).
REFERENCES
RYALTRIS® is a registered trademark of Glenmark Specialty
S.A., used under license.
1 Bausch
Health, Canada, RYALTRIS® Product Monograph, dated
September 21, 2022.
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2 Asthma
Canada, Allergies: Understand and Manage Your Allergies, How
Common Are Allergies? p. 5
https://asthma.ca/wp-content/uploads/2020/06/BreatheEasy-Allergies_optimized_EN.pdf
|
3 IQVIA
Compuscript Audit, MAT October 2022
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SOURCE Bausch Health