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news.Inspire Pharmaceuticals says that it plans to file an investigational new drug application and begin phase II clinical testing of intranasal epinastine for the treatment of seasonal allergic rhinitis, commonly known as hay fever.
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The company announced its intentions regarding the development of the drug following the recent completion of a pre-IND meeting with the FDA.
Inspire expects to submit the IND in the third quarter of 2006 and begin phase II clinical testing by the end of the year.
The phase II program will include clinical and toxicology studies to determine the optimal formulation and dose. The primary phase II trial is expected to be a 14-day dose-ranging trial in 600-700 subjects with seasonal allergies.
“This program fits nicely into our existing commercial operation, provides access to an attractive market and enables us to leverage both our development expertise in the respiratory/allergy therapeutic area and our knowledge of epinastine in the ocular form, Elestat,” said Dr Christy Shaffer, president and CEO of Inspire.