Inspire Pharmaceuticals' phase III trial with epinastine nasal spray for the treatment of seasonal allergic rhinitis (SAR) did not meet its primary endpoint.

"Our analysis of the overall data in this programme 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 United States," said Christy L. Shaffer, Ph.D., president and CEO, Inspire. "We do not plan to allocate any future resources to this programme and will focus on our commercial products and progressing our high-priority development programmes."

The 14-day, randomised, double-blind trial in 798 patients evaluated two concentrations of epinastine (0.10 per cent and 0.15 per cent) at two spray volumes compared to placebo in patients with documented SAR 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.

In 2006, Inspire acquired certain exclusive rights from Boehringer Ingelheim International GmbH to develop and market epinastine nasal spray in the United States and Canada for the treatment of rhinitis.