**Title: QRxPharma Aligns with FDA for MoxDuo NDA Resubmission**
QRxPharma Limited (ASX: QRX, OTCQX: QRXPY) has announced a clear path forward for the resubmission of their New Drug Application (NDA) for MoxDuo, following discussions with the United States Food and Drug Administration (FDA). This advancement marks a critical step in the approval process for QRxPharma’s immediate-release MoxDuo, a dual-opioid pain relief medication.
During a recent meeting, QRxPharma and the FDA defined the specific measures required for approval. These requirements include conducting additional studies to supplement the existing clinical data, as well as analyzing the drug’s efficacy and safety profile. The outlined strategy aims to address the FDA’s previous concerns effectively and demonstrate MoxDuo’s potential benefits in pain management.
John Holaday, Managing Director and CEO of QRxPharma, expressed confidence in the FDA’s guidance, stating that it provides a clear and achievable pathway for MoxDuo’s resubmission. This collaborative effort with the FDA is poised to strengthen the drug’s case by ensuring all requirements are met, thus enhancing the prospects for approval.
Investors should note that while these steps toward approval represent significant progress, success will depend on QRxPharma’s ability to meet the FDA’s requirements through robust clinical data and analysis. Continued updates will be vital to assessing the potential market impact of