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.
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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.
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.
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By GlobalDataAfter 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.
