| Company: | Inspire Pharma |
| Ticker Symbol: | NYSE: ISPH |
| Class Period: | Jan. 30 2004 to Feb 8, 2005 |
| Date Filed: | Feb-08-05 |
| Lead Plaintiff Deadline: | April-04-05 |
| Court: | District, NC |
On Feb. 9, 2005, Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced results of a Phase 3 clinical study of diquafosol tetrasodium for treatment of dry eye. In this study, diquafosol failed to demonstrate statistically significant improvement as compared to placebo for the primary endpoint of the incidence of corneal clearing.
Inspire received an apporavable letter from the FDA in December 2003 for Diquafosol and met with the FDA in January 2004 to clarify requirements for approval. The FDA indicated that an additional clinical study would be required to provide additional evidence for the efficacy of this potential treatment. Inspire informed the market that the new Phase III trial would replicate a previous trial which demonstrated the drugs efficacy. The Company, however, failed to inform the market that the new trial would have a new primary endpoint, at the FDA's urging, one with which the company could not demonstrate the drug's efficacy in the previous trial.
Inspire initiated the Phase 3 trial on June 2, 2004 and it was a double-masked, randomized, placebo-controlled safety and efficacy study of diquafosol tetrasodium 2% ophthalmic solution in patients with dry eye.
If you acquired the securities of the defendants during the Class Period you may, no later than the Lead Plaintiff Deadline shown above, request that the Court appoint you as lead plaintiff through counsel of your choice. You may also choose to remain an absent class member. A lead plaintiff must meet certain requirements.
