US FDA rejects Xaracoll NDA

The US Food and Drug Administration has issued a Refusal to File letter for Xaracoll (bupivacaine HCl collagen-matrix implants), a product candidate for the treatment of postsurgical pain from Ireland-incorporated Innocoll (Nasdaq: INNL), whose shares plunged 49.7% to $0.89 in after-hours trading on Thursday.

Upon preliminary review, the FDA determined that the New Drug 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 that the company submit additional information.

Innocoll says it will request a Type A meeting with the FDA to respond to several issues believed to be addressable and seek clarification of what additional information, if any, will be required. Additional details will be disclosed in the future after discussions with the FDA.