FDA to Review Additional Oxiplex Data

FzioMed, Inc.’s hearing with the FDA’s Dispute Resolution Panel for its Oxiplex PMA (premarket approval) application has been postponed. The hearing was scheduled for June 10, 2014.

The company announced on May 28, 2014 that the Office of Device Evaluation (ODE) is going to take more time to review additional clinical information.

OUS Data

The additional information, which the company expects to submit in June, will consist of analyses of additional data obtained in a clinical investigation of Oxiplex outside the U.S. (OUS) ODE has committed to an expeditious review of this information within 90 days of receipt. If the additional clinical information is determined to be sufficient to support approval, together with previously submitted data, the company would proceed with submission of a PMA amendment. The company intends to renew the dispute resolution process in the fourth quarter if the postponement fails to result in a resolution.

Commenting on this development, FzioMed President and CEO John Krelle stated, “We appreciate the continuing cooperation of ODE staff, the Center Ombudsman’s Office, the Center Director’s Office, and the Commissioner’s team throughout this process. We look forward to working collaboratively with FDA to analyze and evaluate the additional data.”

This is a positive development for the company, as they have been attempting to convince the FDA to accept clinical information from outside the U.S. for a long time.

Application Road

FzioMed has been seeking FDA approval of Oxiplex for more than a decade. The FDA’s Center for Devices and Radiological Health (CDRH) has reviewed data on approximately 500 patients from four peer-reviewed published clinical studies spanning three continents. The company says the totality of data from the various studies submitted to FDA on Oxiplex, combined with extensive clinical success achieved around the world, demonstrate that Oxiplex can offer increased clinical benefit compared to discectomy surgery alone, while presenting no significant safety risk.

FzioMed filed their PMA application in August 2007. The agency’s orthopedic panel met in July 2008 and voted to recommend against approval. The FDA then issued “not approval” letters in September 2008 and once again in January 2010. In October 2011, the company requested supervisory review by the Office of the Center Director of the not approvable decision. A letter issued on October 9, 2012, by William Maisel, M.D., on behalf of the Office of the Center Director, upheld the not approvable decision.

The company then chose to exercise the option to consider the October 9, 2012 decision letter to be a denial of approval of the PMA and requested an administrative review by filing a petition for reconsideration on November 5, 2012. On November 4, 2013, the company announced that FDA Commissioner Margaret Hamburg, M.D. approved their petition for an independent review of their PMA and a rare special Medical Devices Dispute Resolution Panel meeting.

Oxiplex

Oxiplex is an absorbable, clear, viscoelastic hydrogel that is applied during lumbar spine surgery. Oxiplex has been approved for sale in the European Union since 2002 and is now approved in 70 countries. It has been used in more than 350, 000 surgeries worldwide. The company has been working for 12 years to gain FDA approval to market this device in the U.S.