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All Penny News: FDA Serves QRxPharma a Third Complete Response Letter for Moxduo IR


Mississauga, ON -- (SBWIRE) -- 05/27/2014 -- Media, Inc. ( announces its latest article titled “FDA Serves QRxPharma a Third Complete Response Letter for Moxduo IR.”

Companies mentioned in this article include Merck & Co. (NYSE:MRK), Zogenix (NASDAQ:ZGNX), QRxPharma Ltd. (OTCQX:QRXPY), Endo Pharmaceutical (NASDAQ:ENDP), Teva Pharma (NYSE:TEVA) and Actavis (NYSE:ACT).

Article Excerpt:

Investors pay a lot of attention to the comments of U.S. Food and Drug Administration advisory committees because, although not bound to act upon recommendations, the FDA usually follows the advice of its committees when making a final decision on whether or not to approve a new drug for marketing. For example, German drugmaker Boehringer Ingelheim first had its little pink pill flibanerin voted down by an FDA advisory panel in June 2010 and the FDA subsequently did not approve. Incidentally, Sprout Pharmaceutical picked up the drug in 2012 and is still trying to meet FDA requests in order to reach commercialization. Shares of Merck & Co. (NYSE:MRK) lost more than five percent in a few days early this month when an FDA advisory committee voted down an over-the-counter version of the blockbuster Singulair for respiratory allergy symptoms. On the flip side, the FDA once in a while does go against its advisors, such as the case with approval of Zogenix’s (NASDAQ:ZGNX) Zohydro, a long-acting version of the opiate hydrocodone, which has stirred controversy ever since FDA approval late in 2013.

QRxPharma Ltd. (OTCQX:QRXPY) is somewhere in the middle of Sprout and Zogenix, as it has spent years now trying to get its dual opioid Moxduo IR (“immediate release) approved by the FDA. The company is dually listed, with common shares on the Australia Stock Exchange under the ticker QRX and American Depositary Receipts traded in the U.S. (hence the “Y” on the ticker). QRxPharma, which has offices in Sydney, Australia and Bedminster, New Jersey, has developed Moxduo as a first-line therapy for patients with moderate to severe acute pain. The drug, a 3:2 ratio fixed dose combination of morphine and oxycodone, is built upon the premise of delivering a low-dose alternative to traditional formulations of morphine or oxycodone with fewer opioid-related side effects.

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