FDA Approves Innocoll NDA for Xaracoll

FDA has approved an Innocoll Holdings Limited NDA for Xaracoll (bupivacaine hydrochloride) for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair. The company describes Xaracoll as a unique, non-injectable drug-device combination in the form of a bioresorbable collagen implant containing bupivacaine hydrochloride. It is placed directly into the surgical site during surgery and after placement it releases bupivacaine immediately and over time, it says.

Approval was based on safety and efficacy data from two Phase 3 studies which showed that Xaracoll provided statistically significant pain relief through 24 hours versus placebo, according to Innocoll. “Additionally, the proportion of patients who did not receive opioid rescue analgesia through 72 hours in the Xaracoll and placebo treatment groups was 36% and 22%, respectively, in Study 1, and 28% and 12%, respectively, in Study 2.”