ATHLONE, Ireland– Innocoll Biotherapeutics plc, a specialty pharmaceutical company and portfolio business of Gurnet Point Capital, announced today that the following clinical trials have been initiated to support a label expansion of its FDA-approved innovative collagen drug-device, XARACOLL (bupivacaine hydrochloride) implant:
- INN-CB-024 is phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a 300-mg dose of the INL-001 (bupivacaine hydrochloride) implant in patients undergoing abdominoplasty; and
- INN-CB-025 is a phase 3 open-label study of the safety and pharmacokinetics of the INL‑001 (bupivacaine hydrochloride) implant in adults following various open soft-tissue surgeries: open ventral hernia repair, abdominoplasty, open abdominal hysterectomy, laparoscopic-assisted colectomy, and reduction mammoplasty.
“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,” said Louis Pascarella, Innocoll Chief Executive Officer and President. “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.”
INN-CB-024 is a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of the INL 001 (bupivacaine HCl) implant, at 300 mg, in patients following abdominoplasty. On the day of surgery eligible patients will be randomly assigned to treatment in a 1:1 ratio to receive either XARACOLL or placebo collagen implants. Patients will then undergo abdominoplasty under general anesthesia and have either XARACOLL or placebo implanted intraoperatively.
INN-CB-025 is a multicenter, Phase 3, open-label, safety, tolerability and characterization of pharmacokinetics study of the INL 001 (bupivacaine HCl) implant, at 300 mg, in patients following various soft-tissue surgeries: open ventral hernia repair, abdominoplasty, open abdominal hysterectomy, laparoscopic-assisted colectomy and reduction mammoplasty. After a screening period, on the day of surgery, eligible patients will undergo surgery under general anesthesia and have XARACOLL implanted intraoperatively. Efficacy is also an exploratory measure in this study.
Both clinical trials are currently screening and enrolling patients and expect to be fully enrolled by year end, with results expected in the first quarter of 2022.
