FDA Approves Orexo’s Zubsolv for maintenance treatment of opioid dependence

Company expects that the drug will well- received by patients and prescribers, and it anticipates a peak market potential of at least $500 million

Jeffrey Bouley
UPPSALA, Sweden—The U.S. Food and DrugAdministration (FDA) recently granted approval to Orexo AB for Zubsolv(buprenorphine/naloxone) sublingual tablet CIII for use as maintenancetreatment for people suffering from opioid dependence.
 
 
The company and FDA note that the drug should beused as part of a complete treatment plan to include counselling andpsychosocial support.
 
 
Zubsolv is a once-daily tablet with, Orexo says, "anadvanced formulation of buprenorphine and naloxone that fully dissolves withinminutes," adding that compared with other buprenorphine/naloxone treatments, "Zubsolvhas higher bioavailability, faster dissolve time, and smaller tablet size witha new menthol taste."
 
The drug is expected to launch in September throughthe company's subsidiary in the United States, Orexo US Inc. and contract salespartner Publicis Touchpoint Solutions.
 
 
Opioid dependence affects nearly 5 million peopleacross the United States, and although it is a treatable condition, only 20percent of Americans suffering from opioid dependence receive treatment today,Orexo notes, and Zubsolv is intended to provide an additional treatment choice "withnew unique product features that may be important for attracting and retainingmore patients in treatment for opioid dependence."
 
 
"Zubsolv has in previous studies showed a highacceptability compared to the leading treatment modalities in the market," saidNikolaj Sørensen, president and CEO of Orexo. "We expect Zubsolv will be wellreceived by patients and prescribers and we anticipate a peak market potentialof at least $500M."
 
 
Orexo's proprietary technology relating to Zubsolvis protected by patents and patent applications in the United States and othermarkets worldwide. Projected expiry dates for this intellectual property rangefrom 2019 to 2032.
 
SOURCE: Orexo news release
 
 

Jeffrey Bouley

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