QRxPharma Limited today provided feedback on its July 9th End-of-Review (EOR) meeting with the United States Food and Drug Administration (FDA). The meeting was held to discuss the feasibility and requirements for approving Moxduo, an immediate release Dual Opioid, for the treatment of moderate to severe acute pain.
In advance of the meeting, QRxPharma outlined several questions to discuss with FDA to ensure the Company receives clear direction for the Moxduo program. The questions addressed the overall approach for registration of Moxduo, potential study design and the number of clinical studies.
"We were encouraged by the extent of engagement on clinical issues by the Food and Drug Administration, and we found the meeting to be constructive and helpful," said Dr. Edward Rudnic, CEO of QRxPharma.
"We are evaluating the path forward and will utilize this guidance to determine the appropriate next steps."