Innocoll AG Announces First Patient Dosed in the XaraColl MATRIX-1 Phase 3 Study for the Treatment of Postoperative Pain
Postoperative pain management is a serious concern for surgeons and patients. According to Life Science Database, there are over 76 million surgeries performed annually in the US with approximately 1.4 million being hernia operations. Effective postoperative pain control is an essential component of the care of the surgical patient. Inadequate pain control, apart from being inhumane, may result in increased morbidity or mortality. While opioids are very effective analgesics, opioids also carry with them many undesirable potential side effects: sedation, respiratory depression, nausea and vomiting, hypotension and bradycardia, pruritus, and inhibition of bowel function.
XaraColl acts locally following 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 XaraColl collagen matrix helps deliver that local pain relief for up to 72 hours.
“Postoperative pain management is critical for a successful result of nearly any surgical procedure. When pain is adequately controlled, patients have a better experience.” said Dr.
The MATRIX-1 Phase 3 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. The second Phase 3 study, MATRIX-2 is expected to start later this quarter. Each study is expected to enroll approximately 300 patients age 18 and older in
The primary efficacy endpoint is the sum of pain intensity difference (
To qualify for the study, patients must have a planned (non-emergent) unilateral inguinal hernioplasty (open laparotomy, tension-free technique) to be performed according to standard surgical technique under general anesthesia. Following screening and determination of eligibility, study participants will be assigned to one of two groups. Patients will be treated with implantation of three 100 mg XaraColl matrices (total dose 300 mg) or three placebo matrices. Pain measurements will be recorded at predetermined intervals over the first 72 hours following implantation of the matrices. Enrollment is expected to complete in the first quarter of 2016 and topline results from the study are expected in the second quarter of 2016.
More information on the study will be posted at www.clinicaltrials.gov.
“Any statements in this press release about our future expectations, plans and prospects, including statements about the development of XaraColl for treatment of post-operative pain, such as the timing, conduct and outcome of the MATRIX-1 Phase 3 study for XaraColl and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,” “may”, “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including statements about the clinical trials of XaraColl, the potential benefits to patients or surgeons using XaraColl, its effectiveness in delivering pain relief, among other things. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the timing and costs involved in developing and commercializing our products and product candidates, the timing for results, the initiation, conduct and timing of clinical trials, delays in potential approvals by
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