Two placebo-controlled phase 3 pivotal studies evaluating Xaracoll (bupivacaine-collagen bioresorbable implant, Innocoll Holdings) have achieved their primary endpoints, demonstrating postoperative pain relief immediately after open abdominal hernia repair. Xaracoll showed consistency across both studies in its treatment effect for both pain reduction and opioid reduction.
The primary efficacy endpoint––the sum of pain intensity over 24 hours (SPI24) for Xaracoll compared with placebo––met statistical significance in both the MATRIX-1 (P = 0.0004) and MATRIX-2 (P < 0.0001) studies.
A key secondary endpoint in the MATRIX trials was the sum of pain intensity over 48 hours (SPI48). Pooled data from the two MATRIX studies were statistically significant for this endpoint (P = 0.0033). MATRIX-2 achieved a statistically significant result (P = 0.0270), and MATRIX-1 trended toward, but did not achieve, statistical significance (P = 0.0568).
Another key secondary endpoint was the sum of pain intensity over 72 hours (SPI72). Pooled data from the two MATRIX studies for this endpoint were statistically significant, although neither study alone achieved statistical significance for SPI72.
The MATRIX trials also looked at opioid-sparing secondary endpoints. In both studies, Xaracoll significantly reduced total opioid consumption and significantly increased the time before the first use of opioids.
Xaracoll was well tolerated in both trials. The incidence of overall adverse events was similar to that of the placebo arm in each study. There were no Xaracoll-related serious adverse events. The rates of opioid-related adverse events were higher in the placebo arms of both studies.
Based on these results, Innocoll plans to submit a new drug application to the FDA this year. The company anticipates a 2017 product launch.
Xaracoll, a surgically implantable and bioresorbable bupivacaine-collagen matrix, is applied through a simple insertion into the incision and is being developed to provide sustained pain relief by delivering bupivacaine directly at the site of surgical trauma. Bupivacaine is a local anesthetic with well-characterized safety and efficacy profiles.
Source: Innocoll; May 25, 2016.