Inspire reports success in pollen allergy drug study

The phase II clinical trial was a 14-day, randomized, double-blind comparison of two doses of epinastine nasal spray (0.05% and 0.1%) to placebo in 569 subjects who had a documented history of seasonal allergic rhinitis to mountain cedar pollen. The higher dose achieved statistical superiority over placebo. While the most common adverse event observed was bitter taste, it was only reported by 4% of subjects in the 0.05% group and by 5% of subjects in the 0.1% group.

Christy Shaffer, Inspire’s president and CEO, said: “We were pleased that this trial identified an effective dose of epinastine in a nasal spray formulation, demonstrated evidence of acceptable tolerability and reported a low incidence of taste complaints with the two doses evaluated. We believe the taste profile is an important and potentially differentiating attribute for a nasal antihistamine spray.”

Based on the results of this trial and previous discussions with the FDA, Inspire intends to initiate a required six-month nasal toxicology study of epinastine in a single animal species to support longer-term clinical trials. In addition, a meeting with the FDA will be scheduled to discuss the next steps in the clinical program.

In 2006, Inspire acquired certain exclusive rights from Boehringer Ingelheim to develop and market epinastine nasal spray in the US and Canada for the treatment or prevention of rhinitis.