/ — Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC) (“Bausch Health”) and Glenmark Specialty SA, 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 ocular symptoms associated in adults, adolescents and children aged 6 years and older.1
“This Health Canada approval will allow Bausch Health to soon make RYALTRI S available to Canadians, providing an innovative treatment option for seasonal allergic rhinitis,” said Cees Heiman, Senior Vice President, Europe and Canada, Bausch Health. “It’s part of our ongoing commitment to be a trusted partner in the health care of Canadians.”
RYALTRIS is a fixed-dose combination therapy that relieves the symptoms of both nasal and ocular RSA in an easy-to-use nasal spray. Onset of action for relief of nasal symptoms occurs within 15 minutes of administration of RYALTRIS.1
“We are very pleased that Bausch Health, Canada will soon be able to offer the benefits of the new drug RYALTRIS to Canadian patients seeking a new treatment for seasonal allergic rhinitis. RYALTRIS is the result of our relentless efforts to deliver high quality products of medicines that benefit patients around the world and are now coming to Canada, adding to our global respiratory leadership,” said Brendan O’Grady, Chief Executive Officer. – Global Formulations Business, Glenmark Pharmaceuticals Ltd.
The efficacy and safety of RYALTRIS have been established in a clinical study program conducted by Glenmark in over 3,000 patients with RAS. RYALTRIS twice daily provided a statistically significant improvement in nasal and ocular symptoms compared to placebo, as well as a statistically significant onset of action in relieving nasal symptoms compared to placebo at 15 minutes, in three phase studies 3 randomized double-blind (P
Important safety information for RYALTRIS
RYALTRIS is an intranasal spray and should not be taken by mouth, instilled into the eyes, ears or applied to the skin. In 14-day clinical studies in RAS patients taking RYALTRIS twice daily, the most commonly observed adverse events were taste disturbance (3%), nosebleeds (1%), and nasal discomfort ( 1%). RYALTRIS should not be used by anyone who has had an allergic reaction to olopatadine or mometasone or any ingredient in the formulation or who has untreated fungal, bacterial or tuberculosis infections of the respiratory tract. Close medical supervision is required in anyone with a weakened immune system, including those who have had infections with opportunistic pathogens. An increased risk of new onset or potential worsening of pre-existing infections (e.g. tuberculosis) by fungi, bacteria or viruses may occur; including fatal chicken pox, measles and herpes infections in susceptible patients. RYALTRIS should be used under close medical supervision in anyone who has had nosebleeds or a nasal perforation. Recurrence, worsening, or persistence of these nasal problems may occur. The effect of RYALTRIS on pregnancy and through transmission into breast milk is not known. Consult a physician if person is pregnant, planning to become pregnant, or breastfeeding, to ensure it is safe to use.1
REFERENCES 1 Bausch Health, Canada, RYALTRIS Product Monograph
About Bausch Health Companies Inc.
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a diversified global pharmaceutical company whose mission is to improve people’s lives through our healthcare products. We develop, manufacture and market a range of products primarily in the areas of gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our participation of approximately 88.7% in Bausch + Lomb. With our leading sustainable brands, we deliver on our commitments by building 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 operations in the specialty, generic and over-the-counter sectors. It focuses on the key therapeutic areas of respiratory, dermatology and oncology. The company has 10 world-class manufacturing plants across 4 continents and operations in over 80 countries. Glenmark is ranked among the top 100 biopharmaceutical companies in the world (Top 100 Companies Ranked by Pharmaceutical Sales, 2020, by In Vivo/Scrip 100) and among the top 50 global companies in the non-patent sector (Top 50 Generics and Biosimilars Companies ranking by Sales, 2020, by Generics Bulletin/In Vivo). The company has been listed on the Dow Jones Sustainability Index (DJSI), one of the world’s most respected and widely accepted sustainability benchmarks, in the Emerging Markets category (2021) for the fourth consecutive year. For more information, visit www.glenmarkpharma.com.
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