Orexo's Zubsolv receives FDA nod

Opioid dependence affects nearly 5 million Americans, according to SAMHSA

NEW YORK — The Food and Drug Administration has approved a new drug for treating opioid dependence.

Orexo U.S. announced the approval of Zubsolv (buprenorphine; naloxone) sublingual tablets. The drug, Schedule III controlled substance, is approved for use once per day in the maintenance treatment of opioid dependence. Opioid dependence affects nearly 5 million people in the United States, according to the Substance Abuse and Mental Health Services Administration, but about 60% of those affected don't receive treatment.

"Orexo is committed to helping patients suffering from opioid dependence effectively manage their condition," Orexo president Robert DeLuca said. "The advanced formulation of Zubsolv was developed using our proprietary technology to meet the needs of patients not satisfied with previously approved buprenorphine-naloxone formulations."


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