Encouraged by results of a meeting with the U.S. Food and Drug Administration, Inspire Pharmaceuticals plans to conduct Phase III clinical trials on its proposed treatment of allergic rhinitis.
Inspire described its FDA meeting as “productive.” The company discussed results of Phase II clinical trials for epinastine, a nasal spray.
Allergic rhinitis symptoms include nasal congestion, runny nose and nasal itching.
Inspire licensed the drug from Boehringer Ingelheim International GmbH, which is based in Germany. Terms of the deal were not disclosed.
Inspire paid Boehringer Ingelheim an upfront license fee, will fund development efforts, and pay royalties if the drug is approved. The agreement covers Canada and the United States.
The Phase III program is expected to include three trials, two for seasonal rhinitis and another for perennial rhinitis. Trials are expected to start soon, Inspire said.