FDA Approves Xaracoll
FDA Approves Xaracoll (bupivacaine hydrochloride) Implant for Acute Postsurgical Pain Relief Following Open Inguinal Hernia Repair
ATHLONE, Ireland, Aug. 31, 2020 /PRNewswire/ — Innocoll Holdings Limited, a specialty pharmaceutical company and portfolio business of Gurnet Point Capital, announced today that the US Food and Drug Administration (FDA) has approved Xaracoll for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair, a painful and commonly-performed surgery.1
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 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.”
The efficacy and safety of Xaracoll was evaluated in two Phase III studies of identical design in open inguinal hernia repair. The Phase III studies were performed as outpatient surgeries in adults across 39 sites (N=610, Xaracoll Arm N=404, Placebo Arm N=206) in the US. Xaracoll provided statistically significant pain relief through 24 hours versus placebo, the primary endpoint for both studies. The first secondary endpoint of total use of opioid analgesia through 24 hours was also statistically significant. 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 median time to first opioid rescue analgesia in the Xaracoll and placebo treatment groups was 11 hours and 1 hour, respectively, in Study 1, and 6 hours and 1 hour, 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
“In Phase III studies Xaracoll was shown to provide local pain relief in patients undergoing open inguinal hernia repair while also decreasing the amount of opioids needed,” said Wendy Niebler DO, MBA, Chief Medical Officer at Innocoll. “We look forward to sharing our Phase III data with surgeons as we introduce this new option to manage acute pain following open inguinal hernia repair in adults.”
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
Xaracoll is contraindicated in patients with known hypersensitivity to bupvicaine or to any local anesthetic of the amide type or other components of Xaracoll, in addition to use in obstetrical paracervical block anesthesia. Cardiovascular and respiratory vital signs and consciousness should monitored after placement of Xaracoll, especially in patients with hepatic impairment. Cases of methemoglobinemia have been reported in association with use of local anesthetics. Additional anesthetic administration should be avoided within 96 hours following Xaracoll implantation. Local anesthetics may cause fetal harm based on animal data.
You are encouraged to report SUSPECTED ADVERSE REACTIONS, by contacting Innocoll at 1-833-606-1421 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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.
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.
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
Posted: August 2020
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