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Innocoll launches non-opioid, drug-device, Xaracoll implant for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair

Athlone, Ireland
Monday, November 2, 2020, 11:00 Hrs  [IST]

Innocoll Holdings Limited, a specialty pharmaceutical company and portfolio business of Gurnet Point Capital, announced the commercial launch of Xaracoll (bupivacaine HCI) implant for acute postsurgical pain relief up to 24 hours in adults following open inguinal hernia repair, a painful and commonly performed surgery.

Approved by the US Food and Drug Administration (FDA) in August 2020, Xaracoll is a unique, non-injectable, drug-device combination in the form of a fully bioresorbable collagen implant containing bupivacaine hydrochloride. Xaracoll is placed directly into the surgical site during surgery and, after placement, releases bupivacaine immediately and over time.

“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.

In two phase III studies, Xaracoll met the primary endpoint demonstrating statistically significant pain relief through 24 hours in patients undergoing open inguinal hernia repair while also decreasing the amount of opioids needed following surgery. Additionally, the proportion of patients who did not receive opioid rescue analgesia through 72 hours in the Xaracoll and placebo treatment groups was 36% and 22%, respectively, in Study 1, and 28% and 12%, respectively, in Study 2. The most common adverse reactions in clinical trials (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.

Over the next few weeks, Xaracoll will become available to order for next-day delivery. The wholesale acquisition cost of Xaracoll is $234 per surgery.

Xaracoll is a bioresorbable collagen implant providing postsurgical pain relief through the delivery of bupivacaine, a local anesthetic, at the surgical site. Xaracoll implant releases bupivacaine after placement at the surgical site through diffusion from the porous collagen implant, which dissolves over time. Xaracoll was approved in August 2020 by the US Food and Drug Administration (FDA). Xaracoll is a registered trademark of Innocoll Pharmaceuticals Limited.

Xaracoll contains an amide local anesthetic and is indicated in adults for placement into the surgical site to produce postsurgical analgesia for up to 24 hours following open inguinal hernia repair.

Innocoll Holdings Limited is a global specialty pharmaceutical company headquartered in Athlone, Ireland.

Gurnet Point Capital is a unique healthcare fund founded by Ernesto Bertarelli and led by Christopher Viehbacher, who, together, have decades of expertise in an industry for which they share a passion, both as chief executives and as investors.


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