In continuation of my update on bupivacaine
Xaracoll is a unique, non-injectable drug-device combination in the form of a fully bioresorbable collagen implant containing bupivacaine hydrochloride. Xaracoll is placed directly into the surgical site during surgery and, after placement, releases bupivacaine immediately and over time.1,2
“Xaracoll is an advancement in the management of postsurgical pain as it is the first and only drug-device combination product to provide local pain relief following open inguinal hernia repair in adults,” said Innocoll CEO Rich Fante. “The FDA approval is an important milestone for Innocoll and we are excited to bring Xaracoll to market later this year as an effective and well-tolerated, non-opioid treatment option for surgeons.”
The efficacy and safety of Xaracoll was evaluated in two Phase III studies of identical design in open inguinal hernia repair. The Phase III studies were performed as outpatient surgeries in adults across 39 sites (N=610, Xaracoll Arm N=404, Placebo Arm N=206) in the US. Xaracoll provided statistically significant pain relief through 24 hours versus placebo, the primary endpoint for both studies. The first secondary endpoint of total use of opioid analgesia through 24 hours was also statistically significant. Additionally, the proportion of patients who did not receive opioid rescue analgesia through 72 hours in the Xaracoll and placebo treatment groups was 36% and 22%, respectively, in Study 1, and 28% and 12%, respectively, in Study 2. The median time to first opioid rescue analgesia in the Xaracoll and placebo treatment groups was 11 hours and 1 hour, respectively, in Study 1, and 6 hours and 1 hour, respectively in Study 2. The most common adverse reactions in clinical trials (incidence ≥2% and higher than placebo) included incision site swelling, dysgeusia, headache, tremor, blurred vision, seroma, scrotal swelling, pyrexia, oral hypoesthesia, and post procedural discharge.1,3
“In Phase III studies Xaracoll was shown to provide local pain relief in patients undergoing open inguinal hernia repair while also decreasing the amount of opioids needed,” said Wendy Niebler DO, MBA, Chief Medical Officer at Innocoll. “We look forward to sharing our Phase III data with surgeons as we introduce this new option to manage acute pain following open inguinal hernia repair in adults.”
INDICATIONS AND USAGE
Xaracoll contains an amide local anesthetic and is indicated in adults for placement into the surgical site to produce postsurgical analgesia for up to 24 hours following open inguinal hernia repair.
No comments:
Post a Comment