Innocoll receives refusal to file letter from FDA for post-surgical pain candidate

Following a preliminary review of the company's NDA for Xaracoll, filed in October 2016, the FDA concluded that the application was not sufficiently complete to allow for a more substantive review,.

The FDA in its Refusal to File letter, indicated that Xaracoll should be characterized as a drug/device combination among other things. This would need Innocoll to submit additional details before reapplying for a review.

Innocoll CEO 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 revealed that it will request the FDA for a Type A meeting in this regard. It proposes to respond to various issues which it believes are addressable.

The company also stated that it would ask clarification from the US regulator of what additional details it needed, if any.

It added that more details in this development would be revealed following its discussions with the regulator in the coming days.

A bioresorbable bupivacaine-collagen matrix that can be surgically implantable, Xaracoll uses Innocoll’s collagen-based delivery technology dubbed CollaRx. The drug compound is being developed to give continued relief from postsurgical pain directly into the surgical site.

According to Innocoll, Xaracoll is also intended to cut down the need for systemic opioids and the risks associated with them.

In May 2016, the company announced that Xaracoll met its primary point in both the placebo-controlled Phase 3 pivotal studies in patients with acute postoperative pain associated with hernia repair.