RyaltrisSeasonal and perennial allergic rhinitis in patients aged 12 years and older
Development and Regulatory status
Jun 19: In the US, the FDA has issued a complete response letter (CRL) for the New Drug Application for Ryaltris, citing deficiencies in the Drug Master File relating to one of the active pharmaceutical ingredients as well as in the manufacturing facilities, but no deficiencies with the clinical data. The company are confident they will resolve the issues within 6 to 9 months .
May 18: Filed in the US with PDUFA action date Mar 19 .
Oct 17: Glenmark Pharmaceuticals reports plans for NDA submission in the US in 2018 for mometasone/olapatadine nasal spray for treatment of seasonal and perennial allergic rhinitis, based on the data from PIII trials .
Trial or other data
Mar 18: Results reported of a double-blind, randomised, parallel-group PIII trial (n=1180; NCT02631551) of patients (≥12 years) with SAR. Subjects received twice-daily GSP-301, olopatadine, mometasone furoate, or placebo for 14 days. The primary efficacy endpoint was the mean change from baseline in AM and PM reflective total nasal symptom scores (rTNSS), analysed using mixed-effect model repeated measures. GSP-301 significantly improved rTNSS vs placebo (least squares mean difference [95% CI]: -0.98 [-1.38, -0.57], p<0.001) and vs olopatadine (-0.61 [-1.01, -0.21]; p=0.003), but statistical significance was not demonstrated vs mometasone (-0.39 [-0.79, 0.01], p=0.059). The percentages of patients with treatment-emergent AEs were similar across treatment groups .
Dec 17: Results reported from a PIII double-blind, randomised, parallel trial (NCT02709538; n=601) that compared the long term safety and efficacy of mometasone/olopatadine nasal spray, with two placebo nasal spray formulations, for the treatment of patients with (≥ 12 years of age) with perennial allergic rhinitis in the US. Although full data were not released, Glenmark Pharmaceuticals reported that the trial met its primary safety and secondary efficacy endpoints .
Apr 17: PIII trial (NCT02870205) was a four-arm, double-blind, randomized, parallel group, active and placebo-controlled study that enrolled 1,176 adults and adolescents 12 years of age and older for 14-days of twice daily treatment with GSP 301, mometasone (a corticosteroid), olopatadine (a histamine H1-receptor agonist) or placebo. All trial arms utilized the same vehicle and nasal spray delivery system. The primary endpoint was change from baseline in average morning and evening patient-reported 12-hour reflective Total Nasal Symptom Score (rTNSS). Secondary endpoints include safety and tolerability. GSP 301 demonstrated statistically significant and clinically meaningful improvement from baseline in average morning and evening patient-reported rTNSS, compared to placebo (p <0.001), olopatadine (p=0.028), and mometasone (p=0.019). All investigational treatments administered in the trial were well-tolerated, and showed no meaningful differences in reported adverse events (AEs) across study arms. The most common AE occurring in at least 2 percent of patients was dysgeusia