FDA approves sublingual agent for treatment of opioid dependence

FDA has approved a once-daily buprenorphine/naloxone (Zubsolv, Orexo) sublingual tablet CIII for use as maintenance treatment for people with opioid dependence. It should be used as part of a complete treatment plan that includes counseling and psychosocial support. 

Compared with other buprenorphine/naloxone treatments, buprenorphine/naloxone 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 5 million Americans are affected by opioid dependence, and only 20% receive treatment today. Approximately $56 billion is spent on opioid dependence per year. In addition, the average healthcare cost per patient with opioid dependence is 8 times higher compared to nondependent patients. Approximately 17,000 deaths are associated with opioid pain relievers in the United States every year.

“The approval of Zubsolv will not only offer the advantage of ease of administration for patients who may experience difficulty with administration, but also provides the abuse-deterrent mechanism that has been synonymous with the use of pre-existing formulations [Suboxone] of this combination drug,” said Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, Webster, Texas. “The approval and availability of Zubsolv will offer individuals who suffer from opioid dependence another available line of therapy.”