Innocoll doses first patient in MATRIX-1 Phase 3 study

Innocoll AG on Wednesday announced the first patient has been dosed in its MATRIX-1 (Multisite Assessment of Postoperative Pain Reduction wIth XaraColl) Phase 3 study for the treatment of postoperative pain after open hernioplasty with mesh using XaraColl.

According to Life Science Database, there are approximately 1.4 million hernia operations performed annually in the United States. Opioids are effective analgesics, however they have many potentially negative side effects.

"Postoperative pain management is critical for a successful result of nearly any surgical procedure. When pain is adequately controlled, patients have a better experience." James Tursi, chief medical officer at Innocoll, said. "A better experience for the patient means a better experience for the surgeon. Importantly, the ability to limit or reduce exposure to opioids may enable patients to avoid opioid related side effects and potentially opioid related complications."

XaraColl acts locally after implantation at the surgical site and is intended to provide sustained pain relief by delivering appropriate concentrations of bupivacaine directly at the site of surgical trauma for up to 72 hours. Bupivacaine is a long-acting local anesthetic with a well-characterized safety and efficacy profile.

The study is one of two identical randomized, placebo-controlled, double-blinded studies to investigate the safety and efficacy of a surgically implantable and resorbable bupivacaine-collagen matrix.