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news.Orexo announces that it has submitted an application to the US Food and Drug Administration (FDA) for an expanded label of ZUBSOLV (buprenorphine/naloxone CIII sublingual tablet) to include initiation of treatment for opioid dependence.
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Orexo anticipates a potential approval of the expanded label during the third quarter 2015.
The application for initiation of treatment is supported by the data from the ISTART and OX219-007 studies. In the full dataset, Orexo found no difference when comparing ZUBSOLV and generic buprenorphine monotherapy, when used as treatment for the induction of buprenorphine maintenance therapy[1].
"The FDA submission constitutes an important milestone for ZUBSOLV. Today we take an important next step in the evolution of the product, applying for a new indication and expanded label. A label including initiation of treatment will enhance product differentiation and enable Orexo to educate physicians in how to optimally use ZUBSOLV from the first day of treatment." said Nikolaj Sørensen, CEO and President of Orexo AB.
In a survey performed by Orexo among DATA2000 waivered physicians, who are less active in treating opioid dependent patients, initiation of treatment was cited as the main challenge when treating patients for opioid dependence by more than 40-percent of the respondents. 58-percent of the physicians said more education would be a main driver for increasing their use of buprenorphine based treatment.
An induction label would allow Orexo to customize the education to meet the specific needs of these physicians to increase their comfort in treating patients suffering from opioid dependence.
Nikolaj Sørensen, CEO and President of Orexo AB, noted "Many patients suffering from opioid dependence have difficulties in finding waivered physicians, with an expanded label Orexo can take an active role to encourage and educate the waivered, but not active, prescribers in initiation of treatment and improve access to treatment for patient suffering from opioid dependence."