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A sublingual formulation of the partial opioid agonist buprenorphine, combined with naloxone to reduce the potential for misuse and diversion, has been approved by the Food and Drug Administration, the manufacturer announced.
The combination is approved for the maintenance treatment of opioid dependence, as part of a complete treatment plan that should include counseling and psychosocial support.
The manufacturer, Orexo US, will market the product as Zubsolv; it will be available in two dosage strengths: a tablet containing 1.4 mg of buprenorphine and 0.36 mg of naloxone, and a tablet with 5.7 mg of buprenorphine and 1.4 mg of naloxone.
It should be administered once a day and should be used as maintenance for patients who "have been initially inducted using buprenorphine sublingual tablets," according to the prescribing information. The prescribing information includes a chart that provides the corresponding dosage strengths for the two formulations, as guidance when going from induction to maintenance treatment.
A sublingual formulation of the partial opioid agonist buprenorphine, combined with naloxone to reduce the potential for misuse and diversion, has been approved by the Food and Drug Administration, the manufacturer announced.
The combination is approved for the maintenance treatment of opioid dependence, as part of a complete treatment plan that should include counseling and psychosocial support.
The manufacturer, Orexo US, will market the product as Zubsolv; it will be available in two dosage strengths: a tablet containing 1.4 mg of buprenorphine and 0.36 mg of naloxone, and a tablet with 5.7 mg of buprenorphine and 1.4 mg of naloxone.
It should be administered once a day and should be used as maintenance for patients who "have been initially inducted using buprenorphine sublingual tablets," according to the prescribing information. The prescribing information includes a chart that provides the corresponding dosage strengths for the two formulations, as guidance when going from induction to maintenance treatment.
A sublingual formulation of the partial opioid agonist buprenorphine, combined with naloxone to reduce the potential for misuse and diversion, has been approved by the Food and Drug Administration, the manufacturer announced.
The combination is approved for the maintenance treatment of opioid dependence, as part of a complete treatment plan that should include counseling and psychosocial support.
The manufacturer, Orexo US, will market the product as Zubsolv; it will be available in two dosage strengths: a tablet containing 1.4 mg of buprenorphine and 0.36 mg of naloxone, and a tablet with 5.7 mg of buprenorphine and 1.4 mg of naloxone.
It should be administered once a day and should be used as maintenance for patients who "have been initially inducted using buprenorphine sublingual tablets," according to the prescribing information. The prescribing information includes a chart that provides the corresponding dosage strengths for the two formulations, as guidance when going from induction to maintenance treatment.