QrxPharma to resubmit MOXDUO NDA with FDA

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today that the steps necessary for approval of immediate release MOXDUO have been clarified with the United States Food and Drug Administration (FDA). QRxPharma will resubmit its MOXDUO NDA this quarter, with an expected new PDUFA date to be set for Q3 2013.

During the Company's most recent FDA review meeting, QRxPharma presented a position that although the Combination Rule does not require a demonstration of greater efficacy or safety, the data submitted to date indicate a safety advantage for MOXDUO compared to either morphine or oxycodone alone.  Results from Study 022, which demonstrated that oxygen desaturation was less severe with MOXDUO than with oxycodone or morphine, were presented to the full review committee and noted with interest.  The FDA recommended the Company provide a more extensive analysis of Study 022 when the revised MOXDUO New Drug Application (NDA) is resubmitted.

"Throughout the last several years of FDA interactions on MOXDUO, we have followed the Agency's recommendations in designing and implementing clinical trials that demonstrated its effectiveness and safety in acute pain patients," said Dr. John Holaday , Managing Director and Chief Executive Officer, QRxPharma.  "Recent feedback provided clarity as to the complete response action taken on 25 June, 2012 and, based on the FDA's advice and recommendations, we are now preparing our revised NDA for submission this quarter." 

The FDA also voiced for the first time that no precedent exists for their review of combination products where two drugs in the same category are combined (e.g. morphine and oxycodone as "opioids"). Therefore, despite the Agency previously confirming that there were no safety issues in any of the studies that were part of the original NDA, the resubmitted application, including new results from Study 022, will likely undergo review by an Advisory Committee in late Q2 2013. The Advisory Committee will evaluate the approvability of MOXDUO in the management of acute pain. The reliance on Advisory Committees has been made more common or compulsory since the FDA Amendments Act of 2007.

"While US approval of MOXDUO remains our foremost priority and we are optimistic about next steps with the FDA, we also look forward to submitting regulatory filings in Canada, Europe and Australia before the end of the fiscal year that will further support the Company's strategies for commercialising the product around the world," concluded Holaday.

SOURCE QRxPharma Limited