DURHAM, NC—Inspire Pharmaceuticals Inc. (Nasdaq:ISPH) says it plans to go ahead with a Phase 3 clinical trial of its epinastine nasal spray for treating allergic rhinitis.
The company recently completed its end-of-phase 2 meeting with the U.S. Food and Drug Administration.
“Based on the FDA’s guidance at our recent meeting, we feel we are on a clear path forward into Phase 3 clinical development of this product candidate,” said Christy L. Shaffer, president and CEO of Inspire.
Inspire expects to initiate shortly the required 6-month intranasal toxicology study and to have results by mid-2008. These results are necessary to begin the PAR study, which will include one-year safety results required for the New Drug Application (NDA). Inspire intends to initiate the second SAR study and the PAR study in 2008.
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 or prevention of rhinitis.
Inspire stock rose .68 percent at $5.90 a share in pre-market trading Wednesday morning.
For more see: www.inspirepharm.com
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