- RYALTRIS® (olopatadine hydrochloride and
mometasone furoate nasal spray) treats moderate to severe seasonal
allergic rhinitis (SAR) and associated ocular symptoms in adults,
adolescents, and children aged 6 years and older
LAVAL,
QC, and MUMBAI,
India, Sept. 23, 2022 /CNW Telbec/ - Bausch
Health Companies Inc. (NYSE: BHC) (TSX: BHC) ("Bausch Health") and
Glenmark Specialty S.A., a subsidiary of Glenmark Pharmaceuticals
Ltd. (Glenmark), are pleased to announce that RYALTRIS®
(olopatadine hydrochloride and mometasone furoate nasal spray) 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
"This Health Canada approval will allow Bausch Health to
soon make RYALTRIS available to Canadians, providing an innovative
therapy option for seasonal allergic rhinitis," Cees Heiman, Senior Vice-President, Europe and Canada, Bausch Health said. "This is part of
our ongoing commitment to being a trusted partner in the healthcare
of Canadians."
RYALTRIS is a fixed-dose combination therapy that provides
relief for the symptoms of SAR, both nasal and ocular, in one
easy-to-use nasal spray. The onset of action for nasal symptom
relief occurs within 15 minutes after administration of
RYALTRIS.1
"We are very pleased that Bausch Health, Canada will soon be able to bring the benefits
of the novel drug RYALTRIS to the patients in Canada seeking a new treatment for seasonal
allergic rhinitis. RYALTRIS is a result of our consistent
efforts to offer high-quality medicines that benefit patients
around the world, and now coming to Canada, adding to our global respiratory
leadership," said Brendan O'Grady,
Chief Executive Officer - Global Formulations Business, Glenmark
Pharmaceuticals Ltd.
About RYALTRIS®
The efficacy and safety of RYALTRIS® were established
in a clinical studies program conducted by Glenmark in over 3,000
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).
RYALTRIS demonstrated a safety profile typical of that observed
with intranasal drugs of the same class.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. RYALTRIS' effect 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 Companies Inc.
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 approximately 88.7%
ownership of Bausch + Lomb. With our leading durable brands, we are
delivering on our commitments as we build an innovative company
dedicated to advancing global health.
About Glenmark Pharmaceuticals Ltd.
Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is
an innovation-driven global pharmaceutical company with a presence
across Specialty, Generics and OTC businesses. It focuses on the
key 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. Glenmark is ranked
among the world's top 100 biopharmaceutical companies (Top 100
Companies Ranked by Pharmaceutical Sales, 2020, by In Vivo/Scrip
100) and among the world's top 50 companies in the off-patent
sector (Top 50 Generics and Biosimilars Companies ranked by Sales,
2020, by Generics Bulletin/In Vivo). The company was listed on the
Dow Jones Sustainability Index (DJSI), one of the world's most
respected and widely accepted sustainability benchmarks, under the
category of emerging markets (2021) for the fourth consecutive
year. For more information, visit
www.glenmarkpharma.com.
REFERENCES
1
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Bausch Health, Canada,
RYALTRIS® Product Monograph
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SOURCE Bausch Health