The 14-day, randomized, double-blind trial in 798 patients evaluated two concentrations of epinastine (0.10% and 0.15%) at two spray volumes compared to placebo in patients with documented seasonal allergic rhinitis during mountain cedar season in south central Texas. The epinastine treatment groups did not achieve statistical significance compared to placebo for the primary efficacy endpoint of average change from baseline for the reflective Total Nasal Symptom Score (TNSS), defined as the sum of scores for runny nose, itchy nose and sneezing. The drug was well-tolerated and there were no safety concerns in the trial.
Christy Shaffer, president and CEO of Inspire, said: “Our analysis of the overall data in this program and the current competitive environment in allergic rhinitis indicate that epinastine nasal spray does not show potential to meet our desired product profile in the US. We do not plan to allocate any future resources to this program and will focus on our commercial products and progressing our high-priority development programs.”