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QRxPharma Ltd Updates Moxduo NDA Review

Wednesday, 26 Jun 2013 03:57am EDT 

QRxPharma Ltd announced the planned July 17, 2013, US Food and Drug Administration (FDA) Advisory Committee meeting to consider the MOXDUO combination opioid analgesic New Drug Application (NDA) will be delayed in order to allow the Company and the FDA time to fully consider results of recent findings for Study 022. The NDA was re-filed in late February 2013, with the original Advisory Committee meeting scheduled for July 17, 2013, and the Prescription Drug User Fee Act (PDUFA) date was August 26, 2013. While reviewing data from Study 022 in preparation for its Advisory Committee meeting, QRxPharma found that for 17% of the 375 patients, the timing of electronically collected oxygen desaturation information at one trial site did not accurately reflect the local time zone or changes relating to daylight savings time. For these patients, this resulted in a displacement of electronic oxygen desaturation data relative to nurse-reported events by 1 or 2 hours out of the 48-hour study. The Company's initial analysis shows that adjustments for timing should have no significant effect on the conclusion that MOXDUO demonstrated a respiratory safety advantage over equi-analgesic doses of morphine or oxycodone. 

Company Quote

27 Mar 2015