FDA approves XARACOLL (Bubikain hydrochloride) implants for postoperative pain relief.

The U.S. Food and Drug Administration (FDA) has approved XARACOLL® for postoperative pain control for open groin repair, Innocoll announced today.
XARACOLL is a unique, non-injectable combination of drugs-devices in the form of fully bioabsorbed collagen implants containing bubikain hydrochloric acid.
XARACOLL is placed directly at the surgical site during surgery and releases Bubikain immediately and over time.
Innocoll CEO Rich Fante said: "XARACOLL is an advance in postoperative pain management because it is the first and only product that relieves local pain after adult groin repair.
FDA approval is an important milestone for Innocoll and we are pleased to bring XARACOLL to market later this year."
evaluated the efficacy and safety of XARACOLL in two Phase III studies.
III study was conducted at 39 clinical centers in the United States (N-610, 404 cases in the XARACOLL group, and 206 in the placebo group).
XARACOLL provides statistically significant pain relief within 24 hours compared to placebos.
most common adverse reactions in clinical trials (the rate of occurrence was 2% higher than the placebo) included swelling at the indentation site, indigestion, headache, tremor, blurred vision, swelling of the scrotum, fever, etc.
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