Innocoll Biotherapeutics announced today that it initiated two Phase 3 trials to support a label expansion for its collagen drug-device implant.

Athlone, Ireland-based Innocoll’s trials are seeking label expansion for the FDA-approved Xaracoll (bupivacaine hydrochloride) implant, according to a news release.

INN-CB-024, a Phase 3, randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety of a 300mg dose of the INL-001 implant in patients undergoing abdominoplasty. INN-CB-025 is a Phase 3 open-label study of the safety and pharmacokinetics of the INL-001 implant in adults following various open soft-tissue surgeries, including open ventral hernia repair, abdominoplasty, open abdominal hysterectomy, laparoscopic-assisted colectomy, and reduction mammoplasty.

Both trials are screening and enrolling patients at present, with the expectation of being fully enrolled by the end of 2021 with results expected in the first quarter of 2022.

“We are thrilled to announce that our non-opioid, fully bioresorbable collagen drug-device product, Xaracoll, which is currently an approved treatment option for acute postsurgical pain following open inguinal hernia repair in adults, has reached the important milestone of being studied in Phase 3 clinical trials for use in soft tissue surgeries,” Innocoll CEO & president Louis Pascarella said in the release. “Following the clinical success of Xaracoll in open inguinal hernia repair and building upon the supportive Phase 2 data in other soft tissue surgeries, Innocoll is now undertaking the important work of studying the efficacy and safety of Xaracoll in achieving post-surgical pain relief in patients undergoing other soft tissue surgeries.

“We look forward to sharing data on these studies as we continue to expand the body of clinical data for Xaracoll and develop our unique drug-device combination product for use in additional surgeries.”