Gilatech's Antiscarring Gel Dubbed Approvable By FDA
By Mary Welch
Gliatech Inc.'s post-surgical scar-preventing gel, ADCON-L, moved one step closer to the U.S. market with the receipt of an approvable letter from the FDA. Final approval is subject to completion of the manufacturing review process. Gliatech is aiming for a summer product launch.
"We're delighted. We're continuing to move through the FDA process and that is always positive," said Rod Dausch, chief financial officer for the Cleveland-based company. "We were particularly pleased over the labeling agreement where we can have pain relief information on the label. That's a big event."
The FDA's Orthopedics and Rehabilitation Devices Advisory Panel had recommended that pain relief claims be removed from the label, suggesting the label clearly state the gel provides no long-term pain relief.
However, the approvable letter states the FDA will allow Gliatech to say that ADCON-L "improves patient outcome and reduces activity-related pain as compared to the control group."
"Clearly the FDA followed the study of the in-depth review where the clinical data shows that the gel does reduce pain," says Dausch. The labeling will also state ADCON-L "significantly reduces postsurgical scarring and adhesions," and has "no significant adverse events attributed to its use."
Gliatech's stock (NASDAQ:GLIA) closed Thursday at $13.875, up $0.75.
ADCON-L is a carbohydrate polymer gel that provides a physical barrier to post-surgical scarring and adhesions involving the spinal cord and nerve roots.
Scarring after back surgery (and some 400,000 lumbar disc surgeries are performed annually in the U.S.) is a frequent and painful byproduct. In fact up to 40 percent of all patients who have this surgery develop recurrent back pain and have difficulty maintaining a normal lifestyle. Between 5 and 10 percent of all patients require a second operation.
Following final FDA approval, ADCON-L will be marketed to some 5,000 orthopedic surgeons and neurosurgeons in the U.S. via a network of independent sales representatives. So far, Gliatech has signed 22 manufacturers' agents and expects another six to be on board within the next few weeks. Gliatech may use as many as 140 sales representatives. In Europe, ADCON is sold through distributors.
ADCON-L currently is on the market in 29 countries and has been used in more than 12,000 surgeries.
With ADCON-L seemingly on its way to the U. S. market, Gliatech will continue its work in other areas and products. For instance, ADCON-P, a similar product (but a solution rather than a gel) aimed at pelvic and gynecological surgeries is undergoing a pilot human trial, and data should be available by the end of the summer.
Gliatech and partner Janssen Pharmaceutica N.V. of Beerse, Belgium, renewed their Alzheimer's disease collaboration last year and expect to identify a lead compound molecule by the end of the year. Janssen is a subsidiary of Johnson & Johnson, of New Brunswick, N.J. (See BioWorld Today, Oct. 16, 1997, p. 1.) *