Xaracoll® (bupivacaine HCl; Innocoll Pharmaceuticals Limited) implant is now available for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair.
Xaracoll is a bioresorbable collagen-matrix implant designed to deliver bupivacaine HCl to the surgical site. Each implant contains 100mg of bupivacaine HCl (equivalent to 88.8mg bupivacaine) and 75mg of purified Type I collagen. The product is placed directly into the surgical site during surgery and, after placement, releases bupivacaine immediately.
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. Results from both studies showed that Xaracoll achieved a statistically significant sum of pain intensity difference over 24 hours (SPID24) compared with placebo. Xaracoll was also associated with a significant reduction in total opioid consumption and a significant increase in the time prior to first use of opioids.
As for safety, Xaracoll is contraindicated for use in obstetrical paracervical block anesthesia. Moreover, the safety and efficacy of Xaracoll has not been established in other surgical procedures, including orthopedic and boney procedures.
The most common adverse reactions (incidence greater than or equal to 2% and higher than placebo) for Xaracoll are incision site swelling, dysgeusia, headache, tremor, blurred vision, seroma, scrotal swelling, pyrexia, oral hypoesthesia, and post procedural discharge.
“Xaracoll has the potential to be a new standard of care as the first and only drug-device combination product to provide local, non-opioid pain relief to adults following open inguinal hernia repair,” said Innocoll CEO Rich Fante. “Xaracoll provides long-lasting pain relief at the surgical site where pain originates. We are excited to begin sharing more information about this effective, well-tolerated treatment option with surgeons immediately.”
Xaracoll will be launched through a partnership between Mallinckrodt Pharmaceutical’s Acute Care Sales Team and Innocoll’s Hospital Sales Team. The wholesale acquisition cost (WAC) of Xaracoll is $234 per surgery.
Xaracoll is supplied in 4- and 10-count single-use cartons (pouches) with each pouch containing three 100mg implants.
For more information visit xaracoll.com.
- Innocoll announces commercial launch of 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. [press release]. Athlone, Ireland: Innocoll Holdings Limited; October 29, 2020.
- Xaracoll [package insert]. Athlone, Ireland: Innocoll Pharmaceuticals Limited; 2020.