FDA Accepts Orexo’s Zubsolv for Review

Sweden’s Orexo has revealed that the US Food and Drug Administration (FDA) have accepted the New Drug Application (NDA) for their opioid dependence drug, Zubsolv, for review.

Zubsolv is a sublingual formulation of Reckitt Benckiser’s Suboxone which governs a market that is predicted to reach sales of $1.5 billion in 2012 and continues to exhibit solid growth of over 15% each year.

Orexo submitted the application to the FDA on the 6th September 2012.  After an initial evaluation of completeness, the application is now entering the substantive review stage.  The company noted that the drug now has a Prescription Drug User Fee Act (PDUFA) action date of July 6th 2013.

Anders Lundstrom, chief executive of Orexo, commented that the US regulator’s verdict “is yet another step for Orexo towards becoming a fully-integrated specialty pharmaceutical company with a US commercial presence.”  In addition, he added that Orexo has “a good chance of becoming the first company to offer an alternative treatment option to Suboxone.”

Opioid dependence currently affects more than two million Americans, costing society an predicted $25 billion in associated healthcare costs.  Orexo commented that “to differentiate Zubsolv from competitors and maximise the commercial potential, comprehensive clinical development and product life cycle management programmes have now been initiated.”  The organisation are also investigating additional dose strengths and providing an additional flavour of Zubsolv “to complement the current product offering.”


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