Orexo presents new Ph III data for Zubsolv

The US subsidiary of Swedish drug developer Orexo (STO: ORX) says that, in the ISTART Phase III study, Zubsolv (buprenorphine and naloxone) sublingual tablet (CIII) demonstrated comparable patient retention in treatment at day 15 versus Suboxone film (Reckitt Benckiser’s buprenorphine and naloxone brand).

Zubsolv also demonstrated no increased rate of withdrawal symptoms or opioid cravings versus Suboxone film at day 15 and day 22, according to the new data presented at the 25th Annual Meeting and Symposium of the American Academy of Addiction Psychiatry (AAAP) in Aventura, Florida, USA. AAAP marks the first time these data are presented in a peer-reviewed forum, following the release of top-line results in June 2014.

“We look forward to unveil these findings of the ISTART/006 study – the largest clinical trial ever conducted in the United States to assess buprenorphine/naloxone for the treatment of opioid dependence – reinforcing our dedication to advance research in leveraging medication-assisted treatment for opioid dependence,” said Michael Sumner, chief medical officer, Orexo US, adding: “Despite an average 26% to 32% lower dose of buprenorphine in Zubsolv compared to that in Suboxone film used, Zubsolv showed comparable efficacy to Suboxone film, which may help reduce the potential for misuse.”