FDA Approves bupivacaine HCl Implant for Postsurgical Pain in hernia patients
The US Food and Drug Administration (FDA) has approved Xaracoll, a registered trademark of Innocoll Pharmaceuticals Limited., for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair, a painful and commonly-performed surgery.
It is a first-of-its-kind non-opioid drug-device treatment option for such patients.
XARACOLL, surgically implantable and bioresorbable bupivacaine-collagen matrix, is applied through a simple insertion into the incision and is being developed to provide sustained pain relief by delivering bupivacaine HCl directly at the site of surgical trauma. Bupivacaine HCl is a local anesthetic with a well-characterized safety and efficacy profile.
Innocoll recently announced that two placebo-controlled Phase III pivotal studies evaluating XARACOLL (bupivacaine-collagen bioresorbable implant) each achieved the primary endpoint as a post-operative pain relief treatment immediately following open abdominal hernia repair. XARACOLL showed consistency across both studies in the treatment effect for pain reduction and opioid reduction.
The approval quickly followed positive outcomes from 2 placebo-controlled phase 3 studies (MATRIX-1 and MATRIX-2). The Phase III studies were performed as outpatient surgeries in adults across 39 sites (N=610, XARACOLL Arm N=404, Placebo Arm N=206) in the US.
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