Innocoll AG Announces First Patient Dosed in the XaraColl MATRIX-2 Phase 3 Study for the Treatment of Postoperative Pain
The MATRIX-2 Phase 3 study is the second 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 MATRIX-1 study had its first patient enrolled last month. Each study is expected to enroll approximately 300 patients aged 18 and older in
The primary efficacy endpoint is the sum of pain intensity difference (
Enrollment for both studies is expected to complete in the first quarter of 2016 and topline results from the studies are expected in the second quarter of 2016.
Postoperative pain management is a serious concern for surgeons and patients. In the U.S., approximately 750,000 hernia operations are performed annually. 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 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.
“We remain committed to delivering our late-stage portfolio and realizing the potential of these exciting therapeutics for the physicians and patients they serve,” said
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,enrollment and outcome of and the timing of availability of data from the MATRIX-1 and MATRIX-2 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. 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, enrollment and timing of clinical trials, delays in potential approvals by
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