Innocoll said today that the FDA has issued a Refuse-to-File letter halting further review of the company’s NDA for its post-surgical pain candidate Xaracoll®.
Following a preliminary review of Innocoll’s NDA for Xaracoll, filed in October, the FDA concluded that the application was not sufficiently complete to allow for a more substantive review, the company said yesterday.
According to Innocoll, the FDA maintains that Xaracoll should be considered a drug/device combination, which would require the submission of additional information.
Innocoll said it will request a Type A meeting with the FDA to respond to several issues it believes are addressable, as well as seek clarification of what additional information, if any, will be required.
“We expect to work with the FDA over the coming weeks in an effort to address the open issues and to define a path forward for a successful refiling of our application at the earliest point in time,” Innocoll CEO Tony Zook said in a statement.
Xaracoll is a surgically implantable and bioresorbable bupivacaine–collagen matrix designed to provide sustained postsurgical pain relief directly into the surgical site. Xaracoll—which uses Innocoll’s CollaRx® proprietary collagen-based delivery technology—is also designed to reduce the need for systemic opioids and their associated risks, the company said.
The Refuse-to-File letter marks Innocoll’s second setback in less than 2 months. On November 3, the company acknowledged that its diabetic foot infection candidate Cogenzia (gentamicin collagen topical matrix) failed two Phase III trials, based on topline data.
Investors responded to the FDA rebuff on Xaracoll by selling off Innocoll stock, touching off a 55% drop in the company’s share price from yesterday’s closing price of $1.80 to 79 cents in premarket trading as of 9:12 a.m.