QRxPharma receives FDA written acceptance for review of MoxDuo IR NDA

Nov 9 2011

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today it received written acceptance from the United States Food and Drug Administration (FDA) for review of the MoxDuo IR New Drug Application (NDA) filed earlier this year. The FDA also set June 25, 2012 as the PDUFA (Prescription Drug User Fee Act) target date for action on the approval of the MoxDuo IR NDA.

"We are extremely pleased with this important milestone from the FDA and – subject to approval – making plans to launch MoxDuo IR in the second half of 2012 for the treatment to moderate to severe acute pain," said Dr. John Holaday, Managing Director and CEO, QRxPharma.  "This is a testament to the successful clinical trial program conducted by the Company and indicates the path to market is on track, adding value for shareholders and strategic partners."

The FDA letter stated the agency had completed their filing review of the MoxDuo IR NDA submitted on August 24, 2011 and determined the application was sufficiently complete to permit a substantive review.  The FDA notification included useful technical information on chemistry, manufacturing and controls (CMC), as well as the pediatric program to be conducted after drug approval that would enable further marketing exclusivity.  The NDA is the basis for US regulatory approval of MoxDuo IR for the treatment of moderate to severe acute pain, a $2.5 billion segment of the $8 billion spent annually on prescription opioids in the US.

QRxPharma initiated its MoxDuo IR NDA with the FDA in July 2011 with submission of the CMC module and completed the filing requirements in August with the Clinical and Non-Clinical Data package. The NDA was submitted under 505(b)(2) regulations wherein approval for a new drug may be expedited by citing historical published evidence supporting each of MoxDuo's already approved components to supplement the data derived from QRxPharma's robust development program.

To date, more than 700 patients have been treated with MoxDuo IR in seven late-stage clinical trials over the Company's successful Phase 3 program. Clinical data have consistently demonstrated that MoxDuo IR achieves equal or better pain relief with fewer incidences of moderate to severe opioid-related side effects compared to current standards of care.

The US NDA package will also serve as the core component of MoxDuo registration submissions in Europe, Australia, Canada and elsewhere. The Company believes the recently completed Study 022 which demonstrated a clinically significant reduction in respiratory depression compared to equi-analgesic doses of morphine and of oxycodone, the major cause of death from opioids, will add further value for strategic partners, regulators and prescribers. This study will be submitted to the FDA as a NDA safety update at the end of 2011 and facilitate label claim advantages for MoxDuo IR when the European Marketing Authorisation Application (MAA) is submitted in 2012.