Inspire CEO: Dry-Eye Drug's Future Uncertain
Posted October 5, 2006 8:54 a.m. EDT
DURHAM, N.C. — Inspire Pharmaceuticals'
long struggle to win Food and Drug Administration approval for its proposed dry-eye treatment drug is not over yet.
Inspire executives recently met with the FDA again to discuss diquafosol, which would be sold under the name Prolacria if approved. The FDA has rejected it twice - in December of 2004 and a year later.
The latest meeting led to a rather bleak statement from Inspire Chief Executive Officer Cristy Shaffer on Thursday: "We believe our discussions with the FDA have been constructive, but the overall program remains challenging and the outcome is uncertain."
Inspire said it would provide the FDA with additional information and added that it expected to meet with the FDA again.
Inspire stock (Nasdaq: ISPH) traded up 6 cents at $5.20 in late morning trading.
Drug giant Allergan is Inspire's partner in the project.
After the rejection in December 2005, the FDA said: "The submitted clinical studies fail to demonstrate adequate replication of results for the efficacy endpoints and therefore are insufficient to establish efficacy. Based on our review of the submitted data, consistent findings of corneal clearing need to be demonstrated to support the efficacy of the drug product."