FDA approves two new dosing options for ZUBSOLV

The buprenorphine/naloxone CIII sublingual tablet ZUBSOLV from Orexo US has been approved by the U.S. Food and Drug Administration.

ZUBSOLV was designed for the treatment of patients who have developed an opioid dependency.

The approval of ZUBSOLV expands the dosage range of the medication to include six different dosing options. These options are 11.4mg/2.9mg, 8.6mg/2.1mg, 5.7mg/1.4mg, 2.9mg/0.71mg, 1.4mg/0.36mg and the newest dose of 0.7mg/0.18mg.

"The FDA approval of the 0.7mg/0.18mg dose constitutes yet another important milestone for the opioid dependent community and Orexo,” Orexo US President Robert DeLuca said. “We are proud that in just three years we have been able to listen to physicians' concerns regarding the importance of providing greater dosing flexibility for patients and have succeeded in our product development strategy to bring tangible treatment opportunities to the community we serve. ZUBSOLV extends its widest range of dosage strengths offered which further enables single tablet once daily dosing including the lowest dosage strength available.”

The 0.7mg/0.18mg tablet will be made available early next year and will give physicians the widest range of doses. This includes the smallest possible single dose available.