Glenmark Pharmaceuticals has announced that a 52-week Phase 3 trial of its Ryaltris mometasone furoate/olopatadine hydrochloride nasal spray for the treatment of perennial allergic rhinitis (PAR) met its primary and secondary endpoints. The company said that it plans to submit an NDA for Ryaltris for seasonal allergic rhinitis (SAR) early in 2018.
The long term safety trial, which enrolled 601 PAR patients aged 12 and older, compared Ryaltris to two different placebo formulations. Ryaltris was well tolerated, with the most frequent treatment emergent adverse events being nosebleed (4.6%), headache (4.1%), and decrease in taste sensitivity (2%). The study also met the secondary endpoint of improvement from baseline in in average morning patient-reported reflective Total Nasal Symptom Score (rTNSS).
Glenmark Pharmaceuticals President and Chief Medical Officer Fred Grossman said, “Ryaltris has been extensively studied in three Phase 3 trials for SAR, and we are pleased that the addition of this long-term study in patients suffering with PAR met the primary safety and secondary efficacy endpoints. Collectively, these data suggest that Ryaltris is effective and well-tolerated. We have worked closely with the FDA on the clinical development program for Ryaltris, and look forward to providing robust data to support its potential approval.”
Read the Glenmark press release.
