“Results of these robust studies demonstrates that consistent, significant relief from symptoms may be rapidly achieved and sustained with Ryaltris,” said Frank Hampel, Principal Investigator, Central Texas Health Research.
“These findings, combined with prior studies demonstrating the long-term effects of Ryaltris on patient-reported outcomes, present a promising profile for a potential new treatment for SAR.”
PHASE 3 STUDY
The first study in Phase 3 showed that Ryaltris “resulted in statistically significant and clinically meaningful improvements” in nasal symptom scores compared to placebo, which was sustained for the entire treatment duration, the company said.
Results were presented from two studies within Phase 3, involving more than 2,400 patients who were exposed to 14 days of twice-daily treatment with Ryaltris or placebo.
The result was measured as reflective Total Nasal Symptom Score (rTNSS).
It found that there was strong action for the drug (p value) compared to placebo (p=0.001)
“A rapid onset of action with Ryaltris was observed, with an effect seen at 15 minutes post-dose versus placebo in Study 1 (p=0.013) and Study 2 (p=0.028), which was maintained at each subsequent time point assessed,” it said. Side effects included decreased taste sensitivity. with 3.3 to 3.8% patients reported the effect.
It also presented results from a Phase 2 study for the drug, comprising mometasone furoate and olopatadine hydrochloride.
“The study assessed mean change in iTNSS as the primary endpoint. Onset of action was assessed by average change from baseline in iTNSS at time points from five minutes to four hours post-dose versus placebo… Onset of action with twice-daily Ryaltris versus placebo was observed at 10 minutes after the first dose (p=0.019) and was maintained at later time points except at 2.5 hours (p=0.06). Onset of action could not be defined for Ryaltris dosed once-daily,” it said.
The phase 2 study had involved 180 patients and 14 days of treatment with Ryaltris twice-daily or once-daily versus twice-daily azelastine/fluticasone, olopatadine hydrochloride or placebo.