Orexo announces dosing of first patient with Zubsolv in phase III clinical study

Orexo AB (STO:ORX) announces today that the first patient has been dosed with Zubsolv in a phase III study for a new clinical indication for Zubsolv.

Currently all buprenorphine/naloxone combination products licensed in the US are indicated for maintenance treatment only. Following review by the United States Food and Drug Administration (FDA), Orexo has initiated a phase III study, which once completed successfully, will be the basis for an application to expand the Zubsolv label with a clinical indication that encompass induction of treatment. Zubsolv is a novel sublingual formulation of buprenorphine and naloxone, with projected approval for use in maintenance treatment of opioid dependence by the FDA by July 2013.

Approximately 300 patients will be included in this US trial, and the study is expected to be completed in early 2014.

Induction of opioid dependence treatment is currently limited to buprenorphine products not containing naloxone. With a successful study result and subsequent regulatory approval, physicians will be able to prescribe Zubsolv on-label for induction of opioid addiction treatment, and thereby facilitate an easier transition onto such treatment regimen for patients addicted to opioids.

"Orexo is working with the FDA to secure an on-time approval of Zubsolv for use in maintenance treatment. Once approved Zubsolv will be directed to the more than five million US citizens suffering from opioid dependence. Our new clinical research program will ensure that Zubsolv gains an important clinical practice differentiation and will ensure that patients can be offered Zubsolv from when they commence treatment for their opioid addiction", states Nikolaj Sørensen, President and Chief Executive Officer of Orexo.

He continued by adding "Orexo is committed to take a leading role in optimizing treatment of opioid dependence in the US. We have previously conducted acceptance trials for Zubsolv, in which 89% of trial participants favored Zubsolv over the conventional buprenorphine treatment modalities for opioid addiction, to understand how our formulation technology could aid in improving acceptability of buprenorphine treatment. The current clinical research initiative to expand the future labeled indication for use of Zubsolv is a logical next step, and we look forward to report on the data in the first half of 2014"