Innocoll Announces Commercial Launch of XARACOLL® (bupivacaine HCI) 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

ATHLONE, Ireland, Oct. 29, 2020 /PRNewswire/ -- Innocoll Holdings Limited, a specialty pharmaceutical company and portfolio business of Gurnet Point Capital, announced today 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.¹

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.^1,2

"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.^1,3

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.

References

1. Data on file. Innocoll Pharmaceuticals Limited.
2. Leiman D, Niebler G, Minkowitz H. Pharmacokinetics and safety of the bupivacaine collagen-matrix implant (INL-001) compared to liquid bupivacaine infiltration after open inguinal hernia repair. Poster presented at: World Congress on Regional Anesthesia & Pain Medicine; April 19-21, 2018; New York, NY. Accessed July 30, 2020. https://epostersonline.com/ASRAWORLD18/node/1154
3. Velanovich V, Rider P, Deck K, et al. Safety and efficacy of bupivacaine HCl collagen-matrix implant (INL-001) in open inguinal hernia repair: results from two randomized controlled trials. Adv Ther. 2019;36:200-216.

About XARACOLL

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.

INDICATIONS AND USAGE

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.

Limitations of Use

Safety and effectiveness have not been established in other surgical procedures, including orthopedic and boney procedures.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

• Known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of XARACOLL
• Obstetrical paracervical block anesthesia. The use of bupivacaine in this technique has resulted in fetal bradycardia and death

WARNINGS AND PRECAUTIONS

• Dose-Related Toxicity: Monitor cardiovascular and respiratory vital signs and patient's state of consciousness after placement of XARACOLL
• Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use. See full Prescribing Information for more detail on managing these risks

ADVERSE REACTIONS

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.

To report SUSPECTED ADVERSE REACTIONS, contact Innocoll at 1-833-606-1421 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS
Local Anesthetics: The toxic effects of local anesthetics are additive. Avoid additional local anesthetic administration within 96 hours following XARACOLL implantation. If additional local anesthetic administration with XARACOLL cannot be avoided, monitor patients for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.

USE IN SPECIFIC POPULATIONS

• Pregnancy: Based on animal data, may cause fetal harm
• Moderate to Severe Hepatic Impairment: Consider increased monitoring for bupivacaine systemic toxicity

Please see full Prescribing Information. https://xaracoll.com/xaracoll_pi.pdf

About Innocoll Holdings Limited

Innocoll Holdings Limited is a global specialty pharmaceutical company headquartered in Athlone, Ireland. Innocoll Holdings Limited and its subsidiary, Innocoll Pharmaceuticals Limited, are focused on the development and commercialization of pharmaceutical technologies to meet some of today's most important healthcare challenges. Innocoll Holdings Limited is a portfolio business of Gurnet Point Capital. www.innocoll.com

About Gurnet Point Capital

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. With an initial allocation of $2 billion, GPC is investing long-term capital and supporting entrepreneurs in building a new generation of companies. Based in Cambridge, MA, its remit is global, encompassing life sciences and medical technologies. The fund invests across all stages of product development through to commercialization and does so with an approach that is a hybrid of venture and private equity investing strategies. www.gurnetpointcapital.com

SOURCE Innocoll Holdings Limited