FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development

Innocoll Says Diabetes Infection Treatment Missed Endpoints

Nov. 15, 2016

Innocoll has announced that based on top-line data from its Phase III clinical trials of Cogenzia in patients with moderate to severe diabetic foot infections administered in conjunction with systemic antibiotics and wound therapy, the standard of care (SOC), did not meet their primary endpoint of clinical cure of infection after 28 days versus either placebo plus SOC or SOC alone.

The clinical results reveal in an addition of gentamicin delivered topically through Cogenzia, in conjunction with SOC, does not confer sufficient additional clinical benefit over the placebo, administered with SOC, or SOC alone.

Innocoll also submitted a New Drug Application for Xaracoll FDA for the treatment of postsurgical pain.

Clinical results showed statistically significant differences in the primary endpoint, the sum of pain intensity in both studies, as well as statistically significant reductions in opioid use and other secondary endpoints.

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