The Food and Drug Administration (FDA) has approved XaraColl® (bupivacaine hydrochloride; Innocoll Holdings Limited) implant for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair.
XaraColl is a fully bioresorbable collagen-matrix implant designed to deliver bupivacaine hydrochloride to the surgical site. The approval was based on data from 2 placebo-controlled phase 3 studies (MATRIX-1 and MATRIX-2) that evaluated the efficacy and safety of XaraColl for postoperative pain in 610 adults scheduled for open inguinal hernia surgery. The primary end point for both studies was the sum of pain intensity difference over 24 hours (SPID24).
Findings from MATRIX-1 and MATRIX-2 demonstrated that XaraColl met the primary end point achieving a statistically significant SPID24 compared with placebo, (P =.0004 and P <.0001, respectively). In both studies, administration of XaraColl was associated with a significant reduction in total opioid consumption, as well as a significant increase in the time prior to the first use of opioids (median time to first opioid rescue analgesia: MATRIX-1: 11 hours with XaraColl vs 1 hour with placebo; MATRIX-2: 6 hours with XaraColl vs 1 hour with placebo).
With regard to safety, the most common adverse reactions (incidence ≥2% and higher than placebo) included incision site swelling, dysgeusia, headache, tremor, blurred vision, seroma, scrotal swelling, pyrexia, oral hypoesthesia, and post procedural discharge.
“XaraColl is an advancement in the management of postsurgical pain as it is the first and only drug-device combination product to provide local pain relief following open inguinal hernia repair in adults,” said Innocoll CEO Rich Fante. “The FDA approval is an important milestone for Innocoll and we are excited to bring XaraColl to market later this year as an effective and well-tolerated, non-opioid treatment option for surgeons.”
For more information visit innocoll.com.
FDA approves Xaracoll® (bupivacaine HCl) Implant, a non-opioid, drug-device treatment option for acute postsurgical pain relief for up to 24 hours following open inguinal hernia repair in adults. https://www.prnewswire.com/news-releases/fda-approves-xaracoll-bupivacaine-hcl-implant-a-non-opioid-drug-device-treatment-option-for-acute-postsurgical-pain-relief-for-up-to-24-hours-following-open-inguinal-hernia-repair-in-adults-301120771.html. Accessed August 31, 2020.