FDA Approves New Treatment for Opioid Dependence

Caroline Cassels


July 05, 2013

The US Food and Drug Administration (FDA) has approved Zubsolv (buprenorphine/naloxone, Orexo AB) for maintenance treatment of opioid dependence.

Zubsolv is a once-daily, sublingual tablet with a formulation of buprenorphine and naloxone that fully dissolves within minutes.

According to a release issued by Orexo AB, the drug's manufacturer, Zubsolv has higher bioavailability, faster dissolve time, and smaller tablet size, with a new menthol taste that previous research has shown is highly acceptable to patients.

"Orexo has developed Zubsolv as a novel sublingual therapy meeting the needs of millions of patents that suffer from opioid dependence to offer them a new choice of treatment," Nikolaj Sorensen, president and CEO of Orexo AB, said in a press release.

"Zubsolv has, in previous studies, showed a high acceptability compared to the leading treatment modalities in the market. We expect Zubsolv will be well received by patients and prescribers, and we anticipate a peak market potential of at least $500 million," he added.

The company announced that the drug will be launched in September in the United States by its subsidiary Orexo US in partnership with Publicis Touchpoint Solutions.

According to the release, opioid dependence is associated with an annual cost of $ 56 billion in the United States alone.

"In addiction medicine, the recovery process can be challenging. Products designed to meet patient preferences have the potential to more successfully support their recovery. The approval of Zubsolv provides a new treatment option that offers unique advantages specifically designed to meet the unmet needs expressed by patients and has the potential to improve patient adherence, thereby reducing relapse rates and improving successful patient outcomes," Louis E. Baxter Sr, MD, past president of the American Society of Addiction Medicine, said in the same company statement.


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