August 31, 2020
The U.S. FDA has approved Xaracoll® (bupivacaine HCl), an implant manufactured by Innocoll Pharmaceuticals, to provide acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair.
Inguinal hernias occur when a weakened abdominal wall allows the abdomen’s contents to move into a narrow tube (the inguinal canal) located in the groin area. Surgery, while not always immediately necessary, is the only means of repairing these hernias. Surgeons will relocate or remove tissue as required during the procedure, and often use surgical mesh to reinforce the site of the repair. This is because hernias are prone to recurrence. Pain is one of the most common complications of the procedure.
In clinical studies, Xaracoll provided statistically significant pain relief through 24 hours versus placebo and extended the median time until first use of opioid rescue analgesia (11 hours with Xaracoll) compared to placebo (1 hour with placebo).
Xaracoll is a non-opioid local anesthetic intended for single-dose administration. The recommended dose is three implants, each containing 100mg of bupivacaine HCl that is released over time. The implants must be cut in half using aseptic technique before placement. Three halves should be placed below the site of the mesh, and three placed just below the skin closure.
Launch and pricing plants are not yet available.