Innocoll’s Xaracoll receives Refusal to File letter from FDA


Global specialty pharmaceutical company Innocoll (INNL) has received a Refusal to File letter from the US Food and Drug Administration (FDA) for its Xaracoll drug, which is the company’s product candidate for the treatment of patients suffering from post-surgical pain.

After carrying out a preliminary review, the agency came to the conclusion that the application was not sufficiently complete to allow a substantive review.

The application was submitted by the company in October last year.

In the Refusal to File letter, the FDA, among several other things, indicated Xaracoll is a drug / device combination that calls for Innocoll to submit additional information.

"In the Refusal to File letter, the FDA, among several other things, indicated Xaracoll is a drug / device combination that calls for Innocoll to submit additional information."

Innocoll chief executive officer Tony Zook said: “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 re-filing of our application at the earliest point in time.”

Innocoll will request a Type A meeting with the FDA to respond to a wide range of issues that requires to be addressed, as well as seek clarification of what additional information, if any, should be submitted by the company.

After discussions with the agency, additional details will be disclosed by the company.

Xaracoll drug is a surgically implantable and bio-resorbable bupivacaine-collagen matrix, which uses the company’s CollaRx proprietary collagen-based delivery technology.

The drug is being developed to offer sustained post-surgical pain relief to the patients directly into the surgical site, as well as reduce the need for systemic opioids and their related risks.