US FDA accepts QRxPharma's NDA for review for pain drug MoxDuo IR
This article was originally published in Scrip
The US FDA has accepted for review QRxPharma's new drug application (NDA) for MoxDuo IR as a treatment for moderate to severe acute pain and has set 25 June 2012 as the Prescription Drug User Fee Act action date, the firm said.
"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," said QRxPharma CEO and Managing Director Dr John Holaday, noting that treatments for moderate to severe acute pain are a $2.5 billion market.
He said the FDA's notification included "useful" technical information on chemistry, manufacturing and controls, along with the pediatric programme to be conducted after drug approval, which Dr Holaday noted would enable further marketing exclusivity.
Sydney, Australia-based QRxPharma, which has US offices in Bedminster, New Jersey, completed the filing of its MoxDuo IR NDA, which was filed under the 505(b)(2) regulations, in which a publication is permitted to cite historical published evidence, in August.
To date, more than 700 patients have been treated with MoxDuo IR in seven late-stage clinical trials over the firm's Phase III programme.
The firm said its 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 also will serve as the core component of MoxDuo registration submissions in Europe, Australia, Canada and elsewhere, the company said.
QRxPharma said its recently completed study 022, which demonstrated a clinically significant reduction in respiratory depression compared to equianalgesic doses of morphine and of oxycodone – the major cause of death from opioids – "will add further value for strategic partners, regulators and prescribers".
It said it plans to submit the results to the FDA as an NDA safety update at the end of this year. The company said the study also will facilitate labelling claim advantages for MoxDuo IR when its submits the European marketing authorisation application in 2012.