Bausch Health and Glenmark Specialty’s 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.
“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.
“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.
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.
