The US Food and Drug Administration sent Inspire Pharmaceuticals some good news on Thursday, and the ensuing announcement sent the company’s stock price soaring.
The news could mean diquafosol could be on the market early next year, Inspire said.
The FDA said it had granted “priority review” status for Inspire’s new drug application for a treatment of dry eye. Initial action from the FDA should come within the next six months, the company said, noting that such a notice from the FDA acknowledges a drug has the potential to “address a significant unmet medical need.”
“We are pleased that the FDA has granted priority review for diquafosol and we have already begun an active dialogue with the FDA on various aspects of the submission,” said Christy Shaffer, chief executive officer of Inspire. “We are continuing our efforts toward building a commercial infrastructure to co-promote this potential new product with our partner, Allergan. Given the possibility of accelerated action on the diquafosol NDA, we intend to have our sales force ready for a potential first quarter 2004 launch.”
Some 10 million Americans are afflicted with dry eye.