Moxduo® Immediate Release (IR)
QRxPharma’s lead Dual Opioid, Moxduo IR, is targeted to be a first-line therapy for patients with acute 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 FDA has assigned QRxPharma 25 May 2014 as the new Prescription Drug User Fee Act (PDUFA) date which will be preceded by an Advisory Committee meeting expected to be held in early Q2, 2014. In preparation for the NDA filing, meetings with the FDA reaffirmed that Moxduo was shown to be safe and effective, and the Agency requested to see additional information on the respiratory safety profile of Moxduo IR and data validation in the revised NDA. Particularly relevant to approval is QRxPharma’s Phase 3 study demonstrating less severe hypoxia as measured by oxygen saturation levels in post-surgical patients receiving Moxduo compared to those administered morphine or oxycodone alone at equi-analgesic doses. Respiratory depression is the cause of death from opioid overdose and it is believed that no other opioid has ever demonstrated a decreased risk of respiratory depression while providing the same or better pain relief. The Company also believes that its earlier clinical findings indicate that Moxduo may reduce nausea, vomiting, dizziness, sleepiness and headache compared to the widely prescribed opioids, morphine, oxycodone and Percocet®. 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.