Lotus Clinical Research worked closely with Innocoll on this successful pivotal Phase 3 trial in abdominoplasty, providing scientific and regulatory consulting and conducting the study within our CRO and the ERG site network.
Lotus pioneered the development of abdominoplasty as a postsurgical pain model beginning in 2010, and designed and performed the first Phase 2 and Phase 3 efficacy studies in the model in 2015-2016. Lotus introduced this new surgical model to market to address the need for a fast-enrolling, highly standardized and adequately painful soft tissue surgery to accommodate FDA’s soft tissue requirements for acute postoperative pain label claims. Since then, Lotus has played a central role in nearly every abdominoplasty trial performed to date.
ATHLONE, Ireland – [March 2, 2022] – Innocoll Pharmaceuticals Limited, a commercial-stage biotechnology company and portfolio business of Gurnet Point Capital, announced today positive topline results from Study INN-CB-024, a Phase 3 randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of a 300mg dose of XARACOLL, an innovative collagen drug-device implant, in patients undergoing abdominoplasty. Among patients receiving XARACOLL, a reduction in pain intensity and opioid use was observed through 24 hours post-surgery.
Study INN-CB-024 enrolled 366 patients, who were randomly assigned to have either XARACOLL 300mg (n=181) or placebo collagen matrix (n=185) implanted during surgery. The primary outcome measure was the time-weighted sum of pain intensity from time of implantation through 24 hours (SPI24). There was a statistically significant treatment effect for XARACOLL compared to placebo in SPI24 (p = 0.002). Further, approximately three times as many patients in the XARACOLL cohort were opioid free through 24 hours compared to the placebo-collagen matrix group (18.8% versus 6.5%). This data complements the positive results of XARACOLL in acute post-surgical pain following open inguinal hernia repair in adults, for which XARACOLL is currently approved.
The most common treatment emergent adverse events (TEAE) (>=2% for XARACOLL and greater than placebo collagen-matrix) were dysgeusia (2.2% versus 1.6%), incision site swelling (2.8% versus 2.7%), incision site erythema (2.8% versus 2.2%), postprocedural discharge (2.8% vs 1.1%), back pain (7.7% versus 7.6%), pruritus generalized (2.8% vs. 1.6%), rash (2.2% vs. 1.1%), oropharyngeal pain (4.4% vs 1.6%), blood pressure increased (3.3% vs. 1.6%). There was one serious adverse event of surgical drain site infection in a patient that received placebo collagen-matrix that was considered unrelated to treatment. No TEAE led to study discontinuation.
These positive topline Phase 3 clinical trial results will support Innocoll’s soft tissue surgery development program and its anticipated sNDA application to expand the indications for XARACOLL. Additional studies in this development program include surgery types such as abdominoplasty, ventral hernia, hysterectomy, reduction mammoplasty and colectomy.
“We are excited to report the positive results of this Phase 3 clinical trial with XARACOLL. This study supports XARACOLL’s potential for use in post-surgical pain relief in patients undergoing soft tissue surgery,” said Louis Pascarella, Innocoll President and Chief Executive Officer.
Acute postsurgical pain management, especially across soft tissue surgeries, has historically relied on systemically administered treatments, especially opioid medications. Exposure to opioids post-operatively can result in opioid-related adverse reactions like constipation in the short-term, but in addition several publications have reported that receipt of an opioid after surgery is associated with a risk for persistent opioid use 1 year later.1
Gwendolyn Niebler, DO, Innocoll’s Chief Medical Officer added, “We are proud of these results. The prospect of providing a non-opioid treatment option like XARACOLL to more patients looking to manage acute post-surgical pain after soft tissue surgeries is compelling.”
Innocoll Pharmaceuticals Limited is a global biotech pharmaceutical company headquartered in Athlone, Ireland and is a subsidiary of Innocoll Biotherapeutics Holding Limited. The Innocoll group of companies is focused on the development and commercialization of pharmaceutical technologies to meet some of today’s most important healthcare challenges.
Innocoll is a portfolio business of Gurnet Point Capital.
Gurnet Point Capital is a unique healthcare investment platform within the B-Flexion Group and led by a team with deep expertise in an industry for which they share a passion, both as investors and senior executives. GPC invests long-term capital and supports entrepreneurs in building a new generation of companies that deliver outsized returns through active ownership. Based in Cambridge, MA, its remit encompasses life sciences and health care focused businesses, with a particular emphasis on businesses that have high growth potential in the product development and commercialization stages of their evolution. With its strategy of driving best in class operational transformation for these businesses, to create social impact while generating significant economic value, Gurnet is able to deliver differentiated results for its investors and partners. www.gurnetpointcapital.com
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.
WARNINGS AND PRECAUTIONS
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 within96 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