XaraColl®
XaraColl®, CollaRx Bupivacaine Implant, is in late Phase II development for the management of post-operative pain. The product is a biodegradable and fully bioresorbable matrix of purified fibrillar collagen impregnated with the anesthetic, bupivacaine, which has been specifically developed and formulated using Innocoll's proprietary CollaRx sponge technology to provide local analgesia for 24-72 hours post-operatively, thus reducing the need for systemic opioids.
The standard of care for post-operative pain includes administration of systemically acting mu-opioid agonists including morphine. Systemic opioid analgesics are associated with serious side effects including nausea, vomiting, respiratory depression and risk of substance abuse. Locally delivered analgesics administered at the time of surgery would provide a safer, more convenient and cost-effective solution as a lower dose is expected to be needed to achieve a similar efficacy level to existing systemic and local treatments. Importantly, delivering bupivacaine in a collagen matrix presents a lower risk of inadvertent bolus systemic delivery, which may cause respiratory depression and death.
XaraColl® has completed three phase II studies in patients undergoing hysterectomy procedures and open-mesh herniorrhaphy.
In the open-mesh herniorrhaphy phase II study, the sum of the VAS pain scores both at rest and after cough on Day 1 and Overall were statistically significant for XaraColl® vs. placebo, and total opioid rescue over the first 24 hours post-op was less for Bupivacaine Implant vs. placebo sponge group (p=0.074).
In a phase II study with an active comparator, the ON-Q PainBuster (a portable infusion pump delivering bupivacaine solution to the surgical wound), XaraColl® was non-inferior to ON-Q with respect to the use of opioid rescue medication and pain scores throughout the 4-day post-op period, and demonstrated superiority with respect to use of opioid rescue medication over ON-Q at 24 hours post-op at one-sixth the dose.