Under the investigational new drug (IND) application, Innocoll initially plans to conduct a two-way, placebo-controlled, multi-centered Phase II clinical trial in patients with a painful chronic skin ulcer.
The CollaRx bupivacaine implant is intended to provide pain control at the wound site and reduce or eliminate the requirement for systemic analgesics. The product is comprised of a fully biodegradable and bioresorbable matrix of purified fibrillar collagen that is impregnated with the local anesthetic bupivacaine.
It is anticipated that CollaRx bupivacaine topical will provide long-acting analgesia between dressing changes and significantly reduce pain at the time of dressing change. In addition to the analgesia provided by the bupivacaine, the fibrillar collagen matrix is expected to provide supplementary wound healing benefits, ultimately leading to accelerated wound closure.