In short
Californian device company FzioMed®, Inc, is sounding pretty steamed up. The FDA has knocked back its PMA for Oxiplex® spinal surgery gel, that the company says is backed by over ten years clinical experience, 500 patients in studies and over 300,000 patients in total.
The FDA’s expert panel didn’t think the efficacy data passed muster, but Fziomed has subsequently filed a petition for reconsideration.
Background
Oxiplex is an absorbable, clear, viscoelastic gel that is applied during lumbar spine surgery immediately prior to wound closure. Fziomed develops, manufactures and commercialises absorbable surgical biomaterials based on its patented polymer science and its adhesion barriers are used in many surgical applications including orthopedics, hand, tendon, peripheral nerve, gynecology, general surgery… and spine, where it claims number 1 status.
Fziomed has issued a press release in which it says its product has proven itself to be an effective surgical adjuvant that significantly reduces the effects of Failed Back Surgery Syndrome (FBSS) such as leg pain and neurological symptoms following surgery.
And just to add a little spice to the whole affair Fziomed points a rather accusing finger at its regulatory agency, stating that Oxiplex is available in nearly 70 countries, including those in the European Union, Australia, Canada, Brazil, Mexico and South Korea, the United States is the only country to deny an application for approval of Oxiplex.
Furthermore, it points out that there have not been any reports of safety issues associated with the device among more than 300,000 surgical patients who have been treated with Oxiplex. Those safe, successful surgical procedures occurred in countries whose regulatory agencies are science-based and equally as stringent as the U.S. FDA.
The trouble is though, that the FDA’s panel, which comprises 7 experts in the field, while sounding like they were happy with the safety data and saw no safety issues, were unconvinced by the efficacy data. They even sounded like they wanted to approve it, one, Dr Hanley, of Carolinas Medical Center, Charlotte, N.C., voted against approval due to serious concerns over its efficacy. “While I deep down as a spine surgeon want to approve this stuff … I have to reject this, based upon the training and principles of the FDA process.” Although he added; “I think there is a need for something like this and it may well be that in certain patients it can be helpful.”
The trouble with anti-adhesion products always lies in the numbers, the end points and the definitions. In this case, by targeting a reduction in leg pain following application of the gel at specific points in the spine, the numbers required to gain statistical significance are likely to have been astronomical. Soalmost inevitably the FDA panel reports that the overall data doesn’t point to a significant effect, despite the fact that specific subsets did. Their hands were probably tied.
What happens next is that Fziomed has issued a petition for reconsideration under Section 515(g)(2)(a) of the Food Drug Cosmetic Act, Section 562 of the FD&C act and Part 10.33 of Title 21 Code of Federal regulations. Watch this space.
Company comments
“Patients and spine surgeons across the United States are eager to take advantage of the safe, pain-relieving benefits of Oxiplex and hope the FDA will reconsider its decision to deny access to U.S. patients,” said John Krelle, President and CEO of FzioMed, which recently celebrated 16 years in business. “FzioMed strongly believes that there are several significant issues of scientific dispute that warrant review by an independent advisory committee.”
And, in a closing salvo, Mr. Krelle pulled out the jobs card, suggesting that a reversal of the FDA’s decision would mean adding several hundred well-paying jobs to its U.S. operations.
Source: FzioMed, Inc., Business Wire
published: December 10, 2012 in: Clinical Studies/Trials, Regulatory, Spine