Innocoll, a specialty pharmaceutical company based in Ireland, has received a Refusal to File letter from the FDA for Xaracoll (bupivacaine HCl collagen-matrix implants) for the treatment of postsurgical pain.
After a preliminary review, the FDA determined that the application, which was submitted in October 2016, was not sufficiently complete to permit a substantive review. In the Refusal to File letter, the FDA indicated, among other things, that Xaracoll should be characterized as a drug/device combination, which would require Innocoll to submit additional information. The company says it will request a meeting with the FDA to respond to several issues believed to be addressable and to seek clarification on what additional information, if any, will be required.
Xaracoll is a surgically implantable and bioresorbable bupivacaine-collagen matrix that uses a proprietary collagen-based delivery technology. It was developed to provide sustained postsurgical pain relief directly into the surgical site, according to the company. Xaracoll is also designed to reduce the need for systemic opioids and their associated risks.
Source: Innocoll, December 29, 2016.