FDA Panel Recommends Gliatech's Adcon-L

18 December 1997

A US Food and Drug Administration advisory panel has voted eight to oneto recommend approval of Gliatech Inc's Adcon-L (anti-adhesion barrier gel). The company says it is the first product of its kind which is designed to block the formation of excess scar tissue and prevent adhesions between the spinal cord and nerve roots and the surrounding muscle and bone following lumbar disc surgery.

Adcon-L is a carbohydrate polymer gel which is applied to the wound during surgery and is resorbed by the body after four weeks. Approximately 40% of the 400,000 patients who undergo lumbar disc surgery every year in the USA suffer from recurrent back pain and function impairment because of postoperative adhesions.

Clinical Trial Data Data from a European Phase III trial and interim results from a US pivotal study have demonstrated that Adcon-L-treated patients experienced a significant reduction in peridural scarring six months after surgery compared to the control group. Furthermore, in patients who required a second operation due to disc reherniation, those who had been treated with Adcon-L had little or no scar, while control patients had extensive scarring.

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