Positive results were collected from a Phase 3 study of an investigational fixed-dose combination nasal spray for the treatment of seasonal allergic rhinitis (SAR), according to Glenmark Pharmaceuticals.

The olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg] nasal spray (Ryaltris, Glenmark) has been conditionally accepted by the FDA.

Also known as GSP 301 Nasal Spray, the drug met its primary endpoint in achieving clinically meaningful and statistically significant change from baseline in average morning and evening Reflective Total Nasal Symptom Score (rTNSS) compared to placebo in patients aged 6 years to under 12 years that participated in the study, according to Glenmark.

"It has become increasingly important to conduct studies specifically designed for pediatric patients, so that we may gain insights into potential differences in safety, efficacy and dosing compared to studies in adult and adolescent populations," said Mahboob Rahman, Chief Medical Officer at Glenmark Pharmaceuticals, in a prepared statement. "We are pleased to report that the safety and effectiveness observed in this pediatric population is consistent with our overall Phase 3 development program in SAR patients 12 years of age and older. These robust data contribute to the extensive clinical background supporting the effectiveness and tolerability of Ryaltris."

According to the CDC, nearly 20 million adults in the United States are affected by seasonal allergic rhinitis every year. It is the primary diagnosis in more than 11 million physician's visits annually and is estimated to affect more than 7% of adults aged 18 years and over in the United States.

The primary objective of the Phase 3 study was to compare the effectiveness the dombination nasal spray (administered as 1 spray in each nostril, twice daily) versus a placebo nasal spray over 14 days in pediatric subjects (aged ≥6 to <12 year) with SAR. The study randomized 446 patients and 96.6% of patients completed the study.

In the study, patients treated with the combination nasal spray compared to placebo showed a statistically significant improvement for the primary endpoint of average morning and evening rTNSS (p=0.001). Rates of treatment-emergent adverse events (TEAEs) were similar between the combination nasal spray versus placebo (10.4% vs. 12.0%, respectively). The most common TEAEs included distortion of taste sensation, headache, and nose bleed.

Glenmark has studied this combination nasal spray in 7 clinical trials involving more than 4000 adult and adolescent patients (age 12 years and older). Results from those clinical trials have been previously presented at key medical meetings and full results from the study of the drug in pediatric patients aged 6 to under 12 years of age will be published and presented at future meetings.


Glenmark Pharmaceuticals Announces Results from a Phase 3 Study of Ryaltris™, an Investigational Product for the Treatment of Seasonal Allergic Rhinitis, in Patients Aged 6 to Under 12 Years [news release]. Paramus, NJ; May 8, 2019: Glenmark Pharmaceuticals. https://prnmedia.prnewswire.com/news-releases/glenmark-pharmaceuticals-announces-results-from-a-phase-3-study-of-ryaltris-an-investigational-product-for-the-treatment-of-seasonal-allergic-rhinitis-in-patients-aged-6-to-under-12-years-300846005.html. Accessed May 8, 2019.