Shares of Australian biotech company QRxPharma Ltd. (QRX.AX) (QRXPY) (QRXPF) got whacked Wednesday after the company announced that the FDA has issued a complete response letter for its Moxduo IR New Drug Application for the treatment of moderate to severe acute pain.
MoxDuo IR is an immediate-release Dual Opioid pain therapy comprised of a patented 3:2 fixed ratio combination of morphine and oxycodone.
The company has been asked by the FDA to submit additional information with regard to the safety and effectiveness of Moxduo.
QrxPharma said that it is considering its response to the FDA's requests for additional information and has been granted a meeting with the U.S. regulatory agency to clarify the steps required for approval.
John Holaday, Managing Director and CEO of QRxPharma said, "We remain confident in Moxduo as a potential therapeutic option for the millions of patients suffering from moderate to severe acute pain and will continue our efforts to bring this therapy to market."
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