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Innocoll Holdings Ltd. has announced the official launch of the non-opioid drug XARACOLL (Bubikain hydrochloride) implants for the treatment of adult patients with acute pain for up to 24 hours after open groin repair.
XARACOLL, which was approved by the FDA in August 2020, will release Bubikain immediately and last 24 hours by putting it directly into the surgical site during surgery.
Photo: Rich Fante, CHIEF Executive Officer of Innocoll," said: "XARACOLL is expected to be a new standard of treatment as it provides local, non-opioid pain relief for adult patients after open groin palsy repair.
ii Phase III study, XARACOLL significantly reduced pain within 24 hours of a patient's groin groin repair and reduced the amount of opioids needed after surgery.
in study 1, the XARACOLL and placebo treatment groups had 36 percent and 22 percent of patients without opioid analgesics within 72 hours, and 28 percent and 12 percent, respectively, in study 2.
The most common adverse reactions include swelling at the inclement site, indigestion, headache, tremor, blurred vision, scrotum swelling, fever and inadequate oral sensations, and discharge from the hospital after surgery (2%, higher than a placebo).
in the next few weeks, XARACOLL will be available for a wholesale price of $234 per operation.
