Gliatech Inc. is presenting data in Germany today showing that itsAdcon-L product significantly reduced the formation of adhesionsand related symptoms following lumbar disc surgeries.
Results came from a randomized, double-blind 254-patient pivotalstudy of Adcon-L that was conducted at nine centers in Europe. Halfthe patients were treated with the product, applied around nerve rootsat the surgical site, and the other half were untreated controls.
"We are very excited about this because it's the first study to showclinical outcome of a surgical adhesion prevention product," MichaelZupon, Gliatech's vice president of product development andoperations, told BioWorld. "We actually did measure clinicaloutcome, and we showed improvement in the activity of daily livingand in radicular pain," which is characterized by sciatica.
Adcon-L is a semisynthetic carbohydrate polymeric gel designed toprevent excessive scarring following surgery. Scarring and adhesionsthat sometimes occur around the spinal cord after lumbar surgerymay cause tethering of the nerve roots to the surrounding muscletissue or bone, or peridural fibrosis. Adcon stands for adhesioncontrol; L is for lumbar. The Cleveland company also is developingAdcon-T/N to prevent adhesions following tendon and peripheralnerve surgeries, and has other indications in preclinical testing.
Adcon-L and T/N, classified as devices in Europe and the U.S,already have been launched in the Netherlands and France. Data fromthe European pivotal trial was submitted to the regulatory body therein April, as the company seeks continent-wide approval. Pivotal U.S.studies are expected to begin in the third quarter of this year.
Rod Dausch, Gliatech's chief financial officer, said three clinicalfactors were assessed in the European study. They are reduction ofscarring, as measured by magnetic resonance imaging; improvementin activity of daily living, or ADL; and radicular pain, which wasbroken down into those who were pain-free after six months andthose who were not.
Dausch told BioWorld that there was a 23 percent reduction in theamount of scarring in the treated group vs. the untreated control, asmeasured by total amount of scar in each of the 127-person groups.That was statistically significant.
The ADL category looked at 12 activities _ such as driving, liftingand sitting _ some of which were expected to cause pain and somewhich weren't. In all categories, Adcon-L results were better orequivalent, Dausch said, and in four categories the difference wasstatistically significant. Overall, 24 to 53 percent of Adcon-L patientsreported no increase of pain in these activities as compared to thecontrol group.
In radicular pain, 14 percent more Adcon-L patients were pain-freesix months after surgery, and there were 26 percent fewer clinicalfailures (those who still had pain after six months). While those datawere not significant (p = .2), they were when including only those 35years of age and older (p = .05).
Zupon said Gliatech expects a positive response from the regulatoryauthorities in Europe, and approval to launch in June or July.Reimbursement issues still are being discussed in the Netherlands andFrance, and will have to be addressed in all countries where theproduct is approved.
Dausch said 1995 Adcon sales are expected to be slightly more than$1 million. In 1996, the company is looking for sales of about $7million. And in 1997, when U.S. approval is forecast, sales areexpected to be more than $30 million, he said.
Gliatech, which is privately held, already has cost-effectiveness datato help with its government reimbursement issues. It plans to marketthe product in Europe through distributors in each country. n
-- Jim Shrine
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