FzioMed disagrees with FDA panel on Oxiplex gel

California, USA-based FzioMed says that it strongly disagrees with the recommendation made July 15 by the Food and Drug Administration's Orthopedic and Rehabilitation Devices Advisory Panel, that the company's Premarket Approval application for Oxiplex (morphine) gel was not approvable. The advisory panel's action constitutes a recommendation that is not binding on the FDA, notes the firm, adding that the agency may accept or reject the recommendation, modify it, request additional information or take no action.

"We are in the process of scheduling a meeting with FDA to discuss the advisory panel's comments and the steps necessary to resolve the questions that were raised by the panel," said John Krelle, chief executive of FzioMed.

Oxiplex is an absorbable gel used during lumbar laminectomy, laminotomy and discectomy surgical procedures. It is intended to improve patient outcomes by reducing residual pain and symptoms following lumbar spine surgery. The FDA granted expedited review status for Oxiplex because there are no approved alternative products in the US for this debilitating condition. Outside the USA, the product is approved for sale in 49 countries and has been used in more than 100,000 spine surgeries, the firm noted.