FDA Serves QRxPharma a Third Complete Response Letter for Moxduo IR

FDA Serves QRxPharma a Third Complete Response Letter for Moxduo IR

By: Tomas Ronolski - AllPennyStocks.com News

Tuesday, May 27, 2014

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.


Seven clinical trials, including four Phase 3 trials, have been conducted on Moxduo, treating in excess of 800 patients and evaluating the drug candidate against widely used drugs, such as oxycodone, morphine, Endo Pharmaceutical’s (Nasdaq:ENDP) Percocet and more.

Since first filing a new drug application with the FDA in August 2011, it’s been a rocky road for QRxPharma in trying to get the agency’s marketing blessing. The FDA issued a complete response letter in June 2012, asking for additional information on Moxduo before an FDA decision would be made. A resubmission of the NDA in February 2013 was followed by another complete response letter in August, further delaying a decision and resulting in another resubmission of the NDA by QRxPharma in November.

In April, shares of QRxPharma were leveled by about 80 percent as the FDA Anesthetic and Analgesic Drug Products Advisory Committee voted to recommend against approval of Moxduo IR. On Tuesday, news hit that the FDA followed the advice, sending yet another complete response letter to QRxPharma stating that there is not sufficient evidence to support approval of the drug at this time. In order for Moxduo to garner the elusive approval, clear clinical evidence of the drug either being better or safer than oxycodone or morphine alone must be demonstrated.

"We will work with FDA to develop a clinical program that addresses the Agency's feedback and ensure that the completed program will clearly demonstrate Moxduo's benefit," said Dr. Edward Rudnic, chief executive at QRxPharma, in a statement today. Rudnic, previously the company’s COO, took over the job as top exec at QRxPharma at the start of the month, replacing Dr. John Holaday, who stepped down after seven years as CEO.

Investors have to be hoping the Rudnic can work some magic to bring Moxduo to commercialization in the $8 billion U.S. opioid market that is riddled with side effects and abuse. The company is also evaluating regulatory pathways in Europe and other markets with agreements in place with Paladin Labs, Aspen Group, Teva Pharma (NYSE:TEVA) and Actavis (NYSE:ACT) to commercialize Moxduo IR if it can gain a stamp of approval. Further, QRxPharma has Moxduo in IV and controlled release formulations in Phase 2 clinical trials, so approval of the IR version sure would help with clearing future regulatory hurdles.

U.S.-listed shares are coming out of the gate down by 12.8 percent at 34 cents following the FDA news.

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