The Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) for XaraColl® (bupivacaine hydrochloride collagen-matrix implants; Innocoll Holdings Limited) for the management of postsurgical pain after open inguinal hernia surgery.
In October 2016, the Company filed an NDA with the FDA for Xaracoll, but the Agency responded with a Refusal to File (RTF) letter indicating among other things that XaraColl should be characterized as a drug/device combination. The Company addressed certain issues raised in the RTF by conducting an additional short-term pharmacokinetic study and several short-term nonclinical toxicology and biocompatibility studies.
XaraColl is a novel collagen-matrix implant designed to deliver bupivacaine hydrochloride to the surgical site. The resubmission is supported by 2 placebo-controlled phase 3 pivotal studies (MATRIX-1 and MATRIX-2) that evaluated the efficacy and safety of XaraColl for postoperative pain in adults scheduled for open inguinal hernia surgery. The primary end point for both studies was the sum of pain intensity difference over 24 hours (SPID24).
Findings from MATRIX-1 and MATRIX-2 demonstrated that XaraColl met the primary end point achieving a statistically significant SPID24 compared with placebo, (P =.0004 and P <.0001, respectively). In both studies, administration of XaraColl was associated with a significant reduction in total opioid consumption and a significant increase in the time prior to the first use of opioids.
With regard to safety, XaraColl was well tolerated, with the incidence of overall adverse events similar to the placebo arm, and no treatment-related serious adverse events. The placebo arm of each study reported higher opioid-related adverse events.
“The FDA acceptance of the NDA for XARACOLL brings us a step closer to providing a new and innovative nonopioid solution to surgeons and patients looking to manage postsurgical pain,” said Rich Fante, CEO of Innocoll.
A Prescription Drug User Fee Act (PDUFA) target date of August 26, 2020 has been set for this application.
For more information visit innocoll.com.