FDA Approves Orexo’s Zubsolv For Treating Opioid Dependent People

By: Taylor


The United States Food and Drug Administration announced that it has granted approval to Orexo for its Zubsolv™ (buprenorphine/naloxone) sublingual tablet CIII. Zubsolv 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 counseling and psychosocial support. Zubsolv is a once-daily, sublingual tablet with an advanced formulation of buprenorphine and naloxone that fully dissolves within minutes. Compared with other buprenorphine/naloxone treatments, Zubsolv has higher bio-availability, faster dissolve time, and smaller tablet size with a new menthol taste. Zubsolv will be launched in September by Orexo US, Inc and their partner Publicis Touchpoint Solutions.

According to reports from the sources, opioid dependence greatly impacts the U.S. economy, with about $56 billion spent on the it every year. In addition, the average healthcare cost per patient with opioid dependence is eight times higher compared to non-dependent patients. There is also a great impact on human life, with almost 17,000 deaths from opioid pain relievers in the U.S. every year.

While detailing about the approval of the drug by the federal agency, Nikolaj Sørensen, President and CEO of Orexo AB says “Orexo has developed Zubsolv as a novel sublingual therapy meeting the needs of millions of patients who suffer from opioid dependence to offer them a new choice of treatment. 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 $500M,”

While in the same event Louis E. Baxter, Sr., MD, FASAM, past president of the American Society of Addiction Medicine said “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.”

About the Manufacturer Orexo!

Orexo is an emerging specialty pharma company with commercial operations in the United States and R&D in Sweden developing improved treatments using proprietary drug delivery technology. Orexo’s expertise is within the area of reformulation technologies and especially sublingual formulations. The company has a portfolio of revenue-generating US and EU approved products currently marketed under license and a pipeline of several reformulations of approved compounds for areas of unmet medical need.

For more information visit: http://www.unsafedrugs.com/fda-approves-orexos-zubsolv-treating-opioid-dependent-people/

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