| 1 min read
Register for free to listen to this article
Listen with Speechify
0:00
1:00
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
 
 

About the Author

Related Topics

Loading Next Article...
Loading Next Article...
Subscribe to Newsletter

Subscribe to our eNewsletters

Stay connected with all of the latest from Drug Discovery News.

Subscribe

Sponsored

Clear sample tubes are shown in a clear tote with red lids in a sample prep robot with a blue and silver industrial lab background.

The crucial role of sample preparation in biotherapy manufacturing

Discover how better sample preparation can unlock improved assay accuracy and analytical results.
A black mosquito is shown on pink human skin against a blurred green backdrop.

Discovering deeper insights into malaria research

Malaria continues to drive urgent research worldwide, with new therapies and tools emerging to combat the parasite’s complex lifecycle and global burden.
Three burgundy round and linear conformations of oligonucleotides are shown against a black background.

Accelerating RNA therapeutic testing with liver microphysiological platforms

Researchers can now study oligonucleotide delivery and efficacy in a system that models a real human liver.
Drug Discovery News March 2025 Issue
Latest IssueVolume 21 • Issue 1 • March 2025

March 2025

March 2025 Issue

Explore this issue