Moxduo® Immediate Release (IR)
QRxPharma’s lead Dual Opioid, Moxduo IR, is targeted to be a first-line therapy for patients with moderate to severe acute pain.
Moxduo IR is a patent-protected combination of morphine/oxycodone in 3mg/2mg, 6mg/4mg, 9mg/6mg and 12mg/8mg strengths. The lowest strengths, 3/2 and 6/4, have less morphine equivalent opioid than commercially available formulations of morphine or oxycodone, and offer a low-dose alternative for titrating pain relief to patient’s needs while reducing side effects.
The Moxduo IR new drug application (NDA), which serves as the basis for US regulatory approval, was refiled with the United States Food and Drug Administration (FDA) in November 2013. The Company presented to the United States Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee on 22 April 2014, which voted to recommend against approval of Moxduo. The Prescription Drug User Fee Act (PDUFA) date is set for 25 May 2014. In preparation for the NDA filing, meetings with the Pending approval, Moxduo IR will be launched with Actavis in the US (anticipated in Q3, 2014) as a branded opioid to address the treatment of moderate to severe acute pain, a $2.6 billion segment of the $8 billion spent annually on prescription opioids in the US. With Vicodin® losing market share as the leading acute pain opioid due to hepatotoxic levels of acetaminophen (paracetamol) and rescheduling to Schedule 2, Moxduo will be launched into an advantaged marketplace. Vicodin accounted for over 135 million acute pain prescriptions in 2012.