Announcement under Regulation 30 (LODR)-Press Release / Media Release

Bausch Health and Glenmark Announce the approval of RYALTRIS® in Canada

10 days ago



Sentiments detected

Positive 7
  • Bausch Health Companies Inc. (NYSE/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.

  • 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.

  • 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.

  • With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health.

  • 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.

Negative 2
  • 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%).

  • Recurrence, worsening or persistence of these nasal problems can occur.

Mentioned Phrases & Organizations

Important keywords detected (20+)

health (15)
glenmark (13)
nasal (11)
bausch (10)
bausch health (9)
pharmaceuticals (8)
companies (7)
canada (7)
sar (5)
patients (5)
world (5)
global (5)
glenmark pharmaceuticals (5)
pharmaceuticals ltd (5)
spray (4)
seasonal (4)
allergic (4)
ocular (4)
symptoms (4)
infections (4)

Organizations identified (10+)

Glenmark (5)
Bausch Health (5)
SAR (3)
NYSE (2)
TSX (2)
Health Canada (2)
Glenmark Pharmaceuticals Limited (1)
Harish Kuber (1)

Features are experimental.