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Glenmark Pharmaceuticals announces results from new analysis of pooled data on Ryaltris

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Ryaltris, formerly GSP 301 Nasal Spray, is the respiratory pipeline asset and currently under review with the US Food and Drug Administration (FDA) as a treatment of seasonal allergic rhinitis in patients aged 12 years and above

Glenmark Pharmaceuticals has announced results from new analyses of pooled data from clinical studies of Ryaltris (olopatadine hydrochloride and mometasone furoate monohydrate nasal spray), an investigational fixed-dose combination nasal spray for the treatment of seasonal allergic rhinitis (SAR) in patients aged 12 years and above, at the 2019 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI 2019) in San Francisco, California. Ryaltris (also known as GSP 301 Nasal Spray) has been conditionally accepted by the FDA as the brand name.

“The majority of patients affected by SAR report taking medicines to help relieve their symptoms, but approximately 50 per cent of patients report needing multiple prescriptions and over-the-counter therapies, which suggests monotherapies may be inadequate, and a need exists for new combination treatment options, said Mahboob Rahman, Chief Medical Officer, Glenmark Pharmaceuticals. “The findings from these pooled analyses provide robust evidence that a combination nasal spray like Ryaltris may offer fast and sustained relief, with side effects and tolerability similar to monotherapy treatment options,” he added.

In a pooled analysis of efficacy and safety from three SAR clinical trials involving more than 2,900 patients, treatment with Ryaltris demonstrated significant and clinically meaningful improvements in average morning and evening reflective Total Nasal Symptoms Scores (rTNSS) (P<0.001) and instantaneous TNSS (P<0.001) versus placebo. Similarly, Ryaltris provided significant and clinically meaningful improvements in rTNSS and iTNSS versus the monotherapy active controls (olopatadine, P=0.002 and P=0.001, respectively; mometasone, P=0.001 and P<0.001, respectively). Rates of treatment emergent adverse events (TEAEs) were consistent between Ryaltris (13.9 per cent), olopatadine (13.2 per cent), mometasone (7.9 per cent) and placebo (9.5 per cent).

Another pooled analysis of data from the same clinical study population demonstrated a rapid, 15-minute onset of action with Ryaltris (P=0.011). Additionally, the onset of action with Ryaltris treatment was maintained over the duration of the assessment (four hours), in comparison to placebo (P<0.001). Additionally, Ryaltris treatment resulted in statistically significant improvements in ocular symptoms versus placebo on day one through day 14 (P<0.001).

The third pooled analysis of data from this clinical study population showed that treatment with Ryaltris led to statistically significant improvements in overall quality of life, compared to placebo (P<0.001), as demonstrated by the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Activities [RQLQ(S)]. Ryaltris treatment also provided statistically significant improvements versus placebo in each individual domain of RQLQ(S) (P<0.001, all): activities, emotional, eye symptoms, nasal symptoms, non-nose/eye symptoms, practical problems and sleep.

Glenmark Pharmaceuticals has studied Ryaltris in seven clinical trials involving more than 4,000 patients. Results from these trials have been previously presented at key medical meetings.

If approved by the FDA, Ryaltris will be commercialised by Glenmark Therapeutics Inc USA.

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