Innocoll Announces Top-line Results from its Phase 2 Clinical Trial Investigating XaraCollÃ‚® for the Management of Post-operative Pain and Receives "Notice of Allowability" fo...
ASHBURN, Va., Sept. 13, 2011 /PRNewswire/ -- Innocoll, Inc. announced top-line results from its phase 2 clinical trial investigating XaraColl for the management of post-operative pain and also announced it has received a "Notice of Allowability" for its XaraColl patent application in the United States.
The clinical trial was a U.S. multi-centered, double-blind, 2-way study comparing the analgesic effect of XaraColl versus placebo in patients undergoing herniorrhaphy via open laparotomy. Patients receiving XaraColl demonstrated a statistically significant reduction in the total use of opioid medication through 24 and 48 hours post-surgery as well as a statistically significant increase in the time before patients took any opioid medication.
The "Notice of Allowability" received from the United States Patent and Trademark Office for U.S. patent application #20080241245 covers products comprising any amino amide or amino ester anesthetic in a collagen matrix intended for the provision of local analgesia or anesthesia.
Dr. Michael Myers, Innocoll's President and CEO commented, "We are pleased to announce two such important milestones for XaraColl and for the company. XaraColl is an important commercial asset for Innocoll and these latest developments serve as a positive endorsement of its progress to date."
XaraColl is a biodegradable and fully resorbable collagen/bupivacaine matrix formulated and manufactured using Innocoll's proprietary collagen-based drug delivery technology, CollaRx. This technology achieves a high concentration of drug at the target tissue, while maintaining low systemic levels. XaraColl is intended to provide pain control directly at the surgical site and thus reduce the level of additional analgesia required following surgery. The product is available in several different strengths, and is designed such that multiple units can be used per patient, for