Inspire to begin phase 2 trial of intranasal epinastine for seasonal allergic rhinitis

By Elaine Rigoli

Tampa, Fla., May 31 - Inspire Pharmaceuticals, Inc. said it plans to file an Investigational New Drug application and begin phase 2 clinical testing of intranasal epinastine for the treatment of seasonal allergic rhinitis, following the recent completion of a pre-IND meeting with the Food and Drug Administration.

Inspire said it expects to submit the IND application for intranasal epinastine in the third quarter of 2006 and begin phase 2 clinical testing by year-end 2006.

The phase 2 program will include clinical and toxicology studies to determine the optimal formulation and dose, according to a news release.

The primary phase 2 trial is expected to be a 14-day dose-ranging trial in 600 to 700 subjects with seasonal allergies.

Inspire is a biopharmaceutical company located in Durham, N.C.

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