The US Food and Drug Administration has expanded the use of Orexo’s Zubsolv to include induction of buprenorphine maintenance therapy in patients with opioid addiction.
US regulators first approved the drug - a sublingual formulation of Reckitt Benckiser's Suboxone (buprenorphine/naloxone) - in July 2013 as a maintenance treatment for people suffering from opioid dependence.
The green light as an induction therapy will allow doctors to prescribe Zubsolv for transitioning patients from whatever opioid they are dependent on to longer term maintenance therapy, thereby giving the drug an entry point at the start of the treatment pathway.
“The induction indication, along with the coordinated launch of 2.9 mg and 11.4 mg strengths later this year, further differentiates and strengthens the competitive position of Zubsolv giving physicians and opioid dependent patients the flexibility to optimise treatment from induction through stabilisation, maintenance and tapering phases”, noted Robert DeLuca, the Swedish biotech’s president.
Opioid dependence is thought to affect around 5 million people across the US.