Positive data from 24-week study of Zubsolv (buprenorphine/naloxone) in Opioid Dependence-Orexo

Orexo announced data from a 24-week clinical trial assessing the long-term safety and efficacy of Zubsolv (buprenorphine/naloxone) sublingual tablet (CIII) for the maintenance treatment of opioid dependence. The results from Study OX219-008, a multi-center, open-label, 24-week, follow-up study (N=665), establish that Zubsolv is well tolerated and effective for opioid dependent patients following six months of treatment. Study OX219-008 was an extension of the ISTART (Study 006) and Study 007.

The safety profile was consistent with the product labeling for sublingual buprenorphine products. The most common AE was constipation (2.9%) and no individual events were reported in ?5% of patients. There was one serious adverse event (SAE) that was considered treatment-related. In addition less than 1% of the patients exited the study due to treatment failure, which further underpins the medical value of Zubsolv. The results also demonstrated an increase of 15% in employment by the patients participating in the study, which gives evidence of the value of effective treatment of opioid dependence for society.

Comment: Zubsolv is a sublingual formulation of Reckitt Benckiser's Suboxone (buprenorphine/naloxone) which dominates a market that reached sales of about $1.5 billion in 2012 and "continues to display steady growth of more than 15% per year". The Center for Disease Control and Prevention has reported that the deaths of women from overdoses of prescription opioids has increased 415% in the past decade. Opioid dependence affects nearly 5 million people across the US. Although it is a treatable condition, only 20% of Americans receive treatment.