The FDA came through at last for Athlone, Ireland-based Innocoll Holdings Ltd., greenlighting the drug-device combo Xaracoll (bupivacaine HCl) for acute postsurgical pain relief for up to 24 hours in adults after open inguinal hernia repair.

A fully bioresorbable collagen implant, Xaracoll is designed for placement directly into the surgical site as the operation is underway, and starts releasing bupivacaine immediately.

In December 2016, the FDA smacked Innocoll with a refusal to file letter pertaining to the NDA submitted at the end of October that year. Regulators at that point designated Xaracoll as a drug-device combo, which meant that Innocoll had to provide more data for approval. In March 2017, the company took receipt of the agency’s minutes pertaining to the type A meeting held on the matter.

During the type A sit-down, Innocoll proposed an additional short-term pharmacokinetic study and several short-term nonclinical toxicology and biocompatibility trials. The company said it would include in the new package data from those experiments plus more manufacturing details required to address the new combo-product designation and other chemistry, manufacturing and control issues. In March of this year, Innocoll said the FDA had accepted its resubmission and assigned the PDUFA date, which passed last Wednesday without word from the agency.

Formerly a publicly traded firm, Innocoll went private in 2017 by way of a deal with health care investment fund Gurnet Point LP, which acquired Innocoll for $1.75 per share in cash, and up to $4.90 in cash from a contingent value right, for a total potential per share value of up to $6.65 or up to about $209 million in all. Gurnet also provided a term loan of $10 million for the Xaracoll push.

The efficacy and safety of Xaracoll were tested in two phase III studies done as outpatient surgeries in adults across 39 sites in the U.S. (n=610, Xaracoll arm n=404, placebo arm n=206). Xaracoll turned up statistically significant pain relief through 24 hours vs. placebo, the primary endpoint for both experiments. The first secondary endpoint of total use of opioid analgesia through 24 hours was also statistically significant. The proportion of patients who didn’t need opioid rescue analgesia through 72 hours in the Xaracoll and placebo treatment groups was 36% and 22%, respectively, in study 1, and 28% and 12%, respectively, in study 2. The median time to first opioid rescue analgesia in the Xaracoll and placebo groups was 11 hours and one hour, respectively, in study 1, and six hours and one hour, respectively in study 2.

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