QRxPharma, an Australian-based commercial-stage specialty pharmaceutical company, has resubmitted its MOXDUO new drug application (NDA).
At a meeting in early October 2013, the US Food and Drug Administration (FDA) provided QRxPharma with guidance on its requirements for the NDA refiling as well as data validation documentation.
QRxPharma managing director and CEO Dr John Holaday noted the company is confident that its refiled NDA will confirm the validity of the data defining the product's respiratory safety advantages and it is hopeful that the FDA will view them favorably in their consideration of the benefits of immediate release MOXDUO as a therapeutic option for the millions of patients who suffer from acute pain.
"We were encouraged by our candid dialogue with the FDA throughout this process, and will continue to liaise closely with the Agency to bring MOXDUO to market," Dr Holaday added.
The FDA previously confirmed that the company's Combination Rule Trial, Study 008, satisfied efficacy requirements and that there were no efficacy or safety issues identified in any of the studies submitted in the original NDA.
QRxPharma completed an audit of the more than 30 million data points for oxygen desaturation from Study 022.
The company believes these data demonstrate a significant respiratory safety advantage for MOXDUO over equi-analgesic doses of morphine or oxycodone.
Furthermore, MOXDUO provides a lower starting dose and finer dose titration steps than acute pain opioids presently available, giving greater flexibility to physicians and patients as the need for pain relief is balanced with lower risks of side effects.
The company expects the FDA to schedule an advisory committee meeting preceding a Prescription Drug User Fee Act (PDUFA) date six months following this submission, projected for late May 2014.
The revised NDA is the basis for recommencing the regulatory approval for MOXDUO for the treatment of moderate to severe pain, a $2.5bn segment of the $8bn spent annually on prescription opioids in the US.
