Innocoll Announces Positive Phase III Trial Results

Innocoll recently announced that two placebo-controlled Phase III pivotal studies evaluating XARACOLL (bupivacaine-collagen bioresorbable implant) each achieved the primary endpoint as a post-operative pain relief treatment immediately following open abdominal hernia repair. XARACOLL showed consistency across both studies in treatment effect for pain reduction and opioid reduction.

The primary efficacy endpoint, the sum of pain intensity over 24 hours (SPI24) comparing XARACOLL to placebo, met statistical significance in both the MATRIX-1 (p=0.0004) and MATRIX-2 (p<0.0001) studies. These highly statistically significant results make XARACOLL the first long-acting, opioid-sparing, local analgesic to meet primary endpoints of Phase III clinical trials in hernia repair, a highly painful and commonly performed surgery.

A key secondary endpoint in the MATRIX trials was the sum of pain intensity over 48 hours (SPI48). The pooled data of 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). The pooled data of the two MATRIX studies for this endpoint were statistically significant, although neither individual study achieved statistical significance for SPI72.
The MATRIX studies also looked at multiple opioid-sparing secondary endpoints. Both trials demonstrated that XARACOLL significantly reduces total opioid consumption and significantly increases the time prior to the first use of opioids. To preserve the company’s plan to publish the full analysis of the Phase III MATRIX studies at future medical meetings and in peer-reviewed publications, further details regarding secondary endpoints will not be released at this time.

XARACOLL was well tolerated in both studies. Incidence of overall adverse events was similar to the placebo arm of each study. There were no XARACOLL-related serious adverse events. 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 (NDA) to the US FDA this year.

“We are very pleased by these positive top-line results for XARACOLL,” said Innocoll CEO Tony Zook. “These two successful post-operative pain studies validate our proprietary collagen-based technology platform. We are committed to filing our NDA this year and bringing this innovative new treatment to market. Our manufacturing expansion and commercial readiness activities are on-track to support an anticipated launch in 2017.”

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 HCl directly at the site of surgical trauma. Bupivacaine HCl is a local anesthetic with a well-characterized safety and efficacy profile. The data collected on the MATRIX-1 and MATRIX-2 studies show that the use of our XARACOLL proprietary collagen implant as a delivery vehicle for bupivacaine HCl appeared to be safe.

“Available therapies for postoperative pain relief are heavily reliant on opioids, which may cause costly and problematic side effects, and further subject patients to long-term opioid use and abuse,” said Harold S. Minkowitz, MD, Department of Anesthesiology, Memorial Hermann Memorial City Medical Center, Houston, TX. “XARACOLL’s success in a commonly performed and highly painful surgery suggests that XARACOLL could become an important option for the surgical and anesthesia communities in addressing patient satisfaction with pain management options and the need for opioid-sparing approaches to pain reduction.”

Innocoll is a global, commercial-stage, specialty pharmaceutical company that is dedicated to engineering better medicines. Our proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to wound and/or surgery sites, they are designed to provide a range of benefits. For more information, visit www.innocoll.com.