Mallinckrodt’s hospital sales force to begin promoting recently approved XARACOLL®, a first-of-its-kind, fully bioresorbable collagen implant that delivers bupivacaine HCI directly to the surgical site, providing postsurgical pain relief to adults undergoing open inguinal hernia repair
ATHLONE, Ireland, October 19, 2020 – Innocoll Holdings Limited, a specialty pharmaceutical company and portfolio business of Gurnet Point Capital, announced today a U.S. co-promotion agreement for XARACOLL, approved for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair, a painful and commonly performed surgery.1 Mallinckrodt plc, a pharmaceutical company with a long history of success in the postsurgical pain management space, will use its hospital sales force to promote XARACOLL. Innocoll is also planning to field its own complementary hospital sales team in support of the launch of XARACOLL.
Newly approved by the US Food and Drug Administration (FDA) in August 2020, XARACOLL is 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
“We are pleased to have Mallinckrodt join our efforts beginning this quarter to introduce XARACOLL as an effective, well-tolerated, non-opioid treatment option for surgeons performing open inguinal hernia repairs,” said Innocoll CEO Rich Fante. “Mallinckrodt’s strong experience in pain management and long-standing relationships in the hospital setting will be key in accelerating surgeon awareness of XARACOLL.”
In Phase III studies, XARACOLL demonstrated statistically significant pain relief through 24 hours in patients undergoing open inguinal hernia repair while also decreasing the amount of opioids needed following surgery.3 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
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
- 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
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
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.
- Data on file. Innocoll Pharmaceuticals Limited.
- 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
- 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.
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 is a registered trademark of Innocoll Pharmaceuticals Limited.
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