FDA has informed Orexo (STO:ORX) that the Zubsolv New Drug Application (NDA) has been accepted for review, and that the Prescription Drug User Fee Act (PDUFA) action date will be July 6, 2013.
Orexo submitted the application for approval of Zubsolv on September 6, 2012. Following a preliminary assessment of completeness, the application is now entering the substantive review stage. Orexo expects Zubsolv to be approved 10 months after submission to the FDA, in July 2013. The launch of Zubsolv is planned for September 2013.
"Today's notice from the FDA is yet another step for Orexo towards becoming a fully integrated specialty pharmaceutical company with a US commercial presence. We have a good chance of becoming the first company to offer an alternative treatment option to Suboxone®, which is today the leading product in the US market for the treatment of opioid dependence," says Anders Lundström, Orexo's President and CEO.
Opioid dependence is increasingly recognized as a major health problem in the US, with over two million Americans affected, costing society an estimated USD 25 billion in related health care costs. Zubsolv will, once approved by the FDA, be directed towards authorized specialized prescribers. The opioid dependence market currently served with Suboxone is estimated to reach sales of USD 1.5 billion in 2012 and continues to display steady growth of more than 15 percent per year.
To differentiate Zubsolv from competitors and maximize the commercial potential, comprehensive clinical development and product life cycle management programs have now been initiated. The primary focus of these programs is to fully explore and document the therapeutic potential of Zubsolv in initiating treatment of opioid dependence, and to document treatment adherence and patient experiences during maintenance treatment with Zubsolv. In addition, Orexo will be completing documentation of further dose strengths as well as providing one additional flavour of Zubsolv to complement the current product offering.