Glenmark Pharmaceuticals recently said that a Phase 3 study comparing Ryaltris olopatadine hydrochloride to placebo in seasonal allergic rhinitis patients aged 6 up to 12 years achieved its primary endpoint. The 14-day study, which enrolled 446 patients, demonstrated a statistically significant improvement in average Reflective Total Nasal Symptom Score (rTNSS), with a similar safety profile to placebo.
In May 2018, Glenmark submitted an NDA for Ryaltris for the treatment of seasonal allergic rhinitis in patients 12 and older. The PDUFA date for completion of the FDA review was originally set for March 21, 2019; but according to a Glenmark quarterly report, the FDA has reset the PDUFA date to June 21, 2019.
Glenmark Pharmaceuticals Chief Medical Officer Mahboob Rahman commented, “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. 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.”
Glenmark Therapeutics Inc. USA will market Rylatris in the US if the nasal spray is approved. The company has recently announced deals with Seqirus for the rights to commercialize Ryaltris in Australia and New Zealand, with Yuhan for South Korean rights, and with Grandpharma for Chinese rights.
Read the Glenmark Pharmaceuticals press release.
