Feb 17 2012
Innocoll, Inc. announced that it has held an End-of-Phase 2 meeting with the FDA to present the results of the Phase 2 clinical studies completed for XaraColl® and to discuss the proposed safety and efficacy studies to be conducted in Phase 3. XaraColl® is being developed for postoperative analgesia and Innocoll plans to undertake its Phase 3 program in patients undergoing hernia repair. FDA agreed to the Phase 3 clinical studies that Innocoll proposed and confirmed that, if successful, those studies should be sufficient to support a future NDA submission.
Commenting on the announcement, Dr. Michael Myers, Innocoll's President and CEO said, "We are pleased to announce yet another significant milestone for Innocoll. With the recent EU approval of CollaGUARD® Adhesion Barrier and with Cogenzia®, for diabetic foot infections, also ready to start Phase 3, Innocoll's portfolio of late stage assets is stronger than ever."