FDA Approves Zubsolv for Maintenance Treatment of Opioid Dependence

Orexo U.S ORXOF announced that it has received approval from the U.S. Food and Drug Administration (FDA) for Zubsolv (buprenorphine and naloxone) sublingual tablets (CIII). Zubsolv is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. Zubsolv is a once-daily, sublingual tablet with higher bioavailability, a fast dissolve time, smaller tablet size and a new menthol flavor. Opioid dependence is a disease, like hypertension, schizophrenia or diabetes, and affects nearly 5 million people across the United States.i,ii,iii Although it is a treatable condition, about 60 percent of opioid dependent patients in the U.S. do not receive treatment.iii Every year thousands of patients continue to misuse opioids rather than risk public exposure by receiving treatment.iv See full press release