Regulators in the USA have given the green light to Orexo of Sweden's Zubsolv as a treatment for opioid addiction.
The US Food and Drug Administration has approved Zubsolv, a once-daily sublingual formulation of Reckitt Benckiser's Suboxone (buprenorphine/naloxone) which currently dominates the market. It is indicated for use as maintenance treatment for people suffering from opioid dependence and should be used as part of a complete treatment plan to include counselling and psychosocial support.
Zubsolv is expected to provide stiff competition for Suboxone as it has higher bioavailability, faster dissolve time and smaller tablet size (with a new menthol taste). It will be launched in September by Orexo's US subsidiary and its partner Publicis Touchpoint Solutions.
Opioid dependence affects nearly 5 million people across the USA and Orexo says that although it is a treatable condition, only 20% currently receive treatment. Chief executive Nikolaj Sorensen said "we anticipate a peak market potential of at least $500 million".
Noting that Zubsolv is "the third product approved in the USA coming out of our R&D department in Uppsala", he added that opioid dependence "greatly impacts the US economy, with about $56 billion spent on the disease per year". Mr Sorensen concluded by saying that "there is also a great impact on human life, with almost 17,000 deaths from opioid pain relievers in the USA every year".