Australian pharmaceutical company, QRxPharma Ltd. (QRX.AX) (QRXPY.PK) has been issued a Complete Response Letter for its MOXDUO New Drug Application by FDA in order to allow the company additional time to prepare and evaluate respiratory data from Study 022.
MOXDUO is an immediate-release Dual Opioid pain therapy comprised of a patented 3:2 fixed ratio combination of morphine and oxycodone.
This is the second time that QRxPharma is receiving a Complete Response Letter for MOXDUO NDA.
The company was issued a complete response letter for MOXDUO NDA last June, and was asked to submit additional information with regard to the safety and effectiveness of the drug. Accordingly, the company agreed to submit additional data from a trial dubbed Study 022, the analysis of which was completed after the MOXDUO NDA filing in August 2011.
QRxPharma resubmitted the MOXDUO including respiratory safety results of Study 022 in February of this year. The resubmitted MOXDUO was scheduled to be reviewed by an FDA panel on July 17, and the regulatory decision date was originally set for August 26, 2013.
However, on June 26, 2013, the company announced that the planned FDA panel review and the FDA decision date will be delayed as it had to make a data amendment for Study 022.
Now, with the FDA issuing a Complete Response Letter for MOXDUO, allowing the company time to submit additional information, QRxPharma plans to complete its refiling in Q4 2013.
The company expects the FDA to announce its decision on MOXDUO NDA in Q2 2014, preceded by an Advisory Committee meeting.
On the ASX, the stock is down 25.35% to A$0.81.
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