QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today the United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Moxduo New Drug Application (NDA) for the treatment of moderate to severe acute pain. The Agency stated that there was not sufficient evidence to support approval of Moxduo at this time. The Agency indicated clinical information demonstrating a clear benefit over oxycodone and morphine alone, either by efficacy, or safety, in an appropriate patient population, is needed.
The Company is presently reviewing the Agency's feedback and will request a meeting with the FDA to clarify the steps required for approval.
"We will work with FDA to develop a clinical program that addresses the Agency's feedback and ensure that the completed program will clearly demonstrate Moxduo's benefit," said Dr. Edward Rudnic, Chief Executive Officer, QRxPharma.