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Zubsolv (Buprenorphine/Naloxone) Wins FDA Nod for Induction of Maintenance Therapy in Opioid-Dependent Patients

Treatment uses 30% lower dose of buprenorphine

The FDA has approved Zubsolv (buprenorphine/naloxone CIII sublingual tablets, Orexo AB) for the induction of buprenorphine maintenance therapy in patients with opioid dependence.

The new approval is based on data from two phase III studies, which showed that Zubsolv is an effective treatment for opioid dependence with a favorable safety profile. The combo tablet was originally approved in July 2013.

Induction is the initial process a physician performs when a patient is transitioned from the opioid on which he or she is dependent to Zubsolv for long-term maintenance treatment of opioid dependence.

The approval of the expanded indication for Zubsolv was supported by combined data from the Induction, STabilization, Adherence and Retention Trial (ISTART) and from Study OX219-007, which showed positive results in more than 90% of Zubsolv-treated patients using a formulation with a 30% lower dose of buprenorphine.

No significant differences were observed between the safety profiles of Zubsolv and generic buprenorphine. The most common treatment-related adverse events during the induction phase for Zubsolv and generic buprenorphine included nausea (3.5% vs. 5.3%, respectively) and headache (5.2% vs. 5.5%).

Zubsolv should be used as part of a comprehensive treatment plan, which includes counseling and psychosocial support. Treatment should be initiated under the direction of physicians who are certified under the Drug Addiction Treatment Act of 2000, and who have been assigned a unique identification number.

Zubsolv sublingual tablets can be abused in a manner similar to other opioids –– legal or illicit. Clinical monitoring appropriate to the patient’s level of stability is essential. Liver function should be monitored before and during treatment. Children who take Zubsolv sublingual tablets can experience severe, possibly fatal, respiratory depression.

Sources: Orexo AB; August 11, 2015; and Zubsolv; 2015.


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