The US Food and Drug Administration (FDA) has approved Orexo's Zubsolv (buprenorphine/naloxone) sublingual tablet CIII for the maintenance treatment of opioid dependence.
Indicated for use as part of a complete treatment plan, including counseling and psychosocial support, the once-daily, sublingual tablet is an advanced formulation of buprenorphine and naloxone.
Expected to be launched in September 2013 by Orexo US and the company's partner Publicis Touchpoint Solutions, the small sized menthol flavored Zubsolv tablet with higher bioavailability dissolves quickly.
Orexo president and CEO Nikolaj Sirensen said Zubsolv is developed as a novel sublingual therapy to meet the needs of millions of patients that suffer from opioid dependence by offering them a new choice of treatment.
"Zubsolv has in previous studies showed a high acceptability compared to the leading treatment modalities in the market," Sirensen added.
"We expect Zubsolv will be well received by patients and prescribers and we anticipate a peak market potential of at least $500M."
The approval is based on the advanced formulation capabilities and proprietary technology, according to Orexo.
Proprietary technology relating to Zubsolv is protected by patents and patent applications in the US and other global markets with likely expiry dates ranging from 2019 to 2032.
