Sublingual agent approved for treatment of opioid dependence

July 25, 2013

The U.S. Food and Drug Administration has approved a new tablet for use in helping patients with opioid dependence.

The FDA has approved a once-daily buprenorphine/naloxone (Zubsolv, Orexo) sublingual tablet CIII for use as maintenance treatment for people with opioid dependence. It offers an additional line of therapy to dependents and should be used as part of a complete treatment plan including counseling and psychosocial support.

Compared with other buprenorphine/naloxone treatments, this product is said to have higher bioavailability, faster dissolve time, and smaller tablet size with a new menthol taste.It will be launched in September by the company’s subsidiary Orexo US, and partner Publicis Touchpoint Solutions.

Nearly five million Americans are affected by opioid dependence, and only 20% receive treatment. The average healthcare cost per patient with opioid dependence is eight times higher than nondependent patients. Annual spending  on opioid dependence is about $56 billion.

For patients who experience difficulty with administration, Zubsolv will offer ease and provide the abuse-deterrent mechanism synonymous with the use of pre-existing formulations of the drug.

Orexo 1-888-Zubsolv  |   www.orexo.com