Xaracoll (bupivacaine HCl collagen-matrix implants) filed with FDA for postsurgical pain- Innocoll

Innocoll announced the submission of a New Drug Application (NDA) for Xaracoll (bupivacaine HCl collagen-matrix implants) to the U.S. FDA for the treatment of postsurgical pain. The submission was based upon the successful results of the MATRIX phase III trials which showed statistically significant differences in the primary endpoint, the sum of pain intensity in both studies, as well as statistically significant reductions in opioid use and other secondary endpoints.

Comment: XaraColl acts locally following implantation at the surgical site to provide sustained pain relief by delivering appropriate concentrations of bupivacaine directly at the site of surgical trauma for up to 72 hours. Bupivacaine is a long acting local anesthetic with a well-characterized safety and efficacy profile. The XaraColl collagen matrix helps deliver that local pain relief for up to 72 hours.