ProlacriaTreatment for Dry Eye
Inspire Pharmaceuticals Announces Outcome of Meeting with the FDA on Diquafosol-An Additional Clinical Study is Required for Further FDA Review-
DURHAM, NORTH CAROLINA - January 30, 2004 - Inspire Pharmaceuticals, Inc. (Nasdaq: ISPH) met with the Food and Drug Administration (FDA) on January 29th regarding the approvable letter received on December 19, 2003 for diquafosol tetrasodium ophthalmic solution for the treatment of dry eye. The purpose of the meeting was to gain clarity from the FDA on requirements for the approval of diquafosol. While we have demonstrated efficacy in one of the pivotal trials submitted as part of the original New Drug Application (NDA), the FDA requires that an additional clinical study be conducted to confirm or replicate this efficacy.
In preparation for yesterday's meeting, Inspire had submitted to the FDA additional clinical data from study 03-108, a Phase III study completed after submission of the NDA. The FDA indicated that the findings from study 108 are not sufficient to address the requirement for an additional clinical study as stated in the approvable letter.
"We now have clarity on what we need to do in moving forward toward product approval and have already begun plans for an additional study," stated Christy L. Shaffer, Ph.D., Inspire CEO. "We plan to initiate a new study as quickly as possible, while taking the time needed to involve the FDA in review of the study protocol to ensure that the study design is acceptable. We believe that our experience, and that of our partner, Allergan, will be valuable in designing a study that is optimized for success. I will be providing an update on our other programs in development as well as our launch of Elestat™ in our conference call this morning."
Source: Inspire Pharmaceuticals, Inc.
Posted: January 2004
- Inspire Continues Discussions with FDA on Dry Eye Program - October 5, 2006
- Inspire Announces Outcome of FDA Meeting on Dry Eye Program - March 28, 2006
- Inspire Announces Receipt of FDA Approvable Letter for Diquafosol - December 2, 2005
- Inspire Submits Amendment to New Drug Application for Diquafosol for the Treatment of Dry Eye - June 1, 2005