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Zubsolv (OX219) Poised to Enter U.S. Opioid-Dependence Market

Drug will compete with Suboxone (Sept. 21)

In a meeting held on September 21, the Swedish specialty pharmaceutical company Orexo presented its views on the future market for the treatment of opioid dependence in the U.S. Recent estimates indicate that the annual cost to society of opioid dependence in America totals $55.7 billion.

Based on the continued growth in the use of prescription-based opioid products in the U.S. and on the associated growth in the nonmedical use of prescription opioids, Orexo projects that the U.S. market for the treatment of opioid dependence will continue to grow, reaching $2 billion in value by 2014. In addition to these main drivers, an increasing number of patients have sought treatment for their opioid dependence in recent years, and data suggest that these patients are likely to be treated over longer periods, the company said.

Orexo also presented its activities for differentiating Zubsolv (OX219), a new sublingual formulation of buprenorphine and naloxone, from the drug’s only established competitor in the U.S. market, Reckitt Benckiser’s Suboxone (buprenorphine and naloxone). Orexo plans to initiate a clinical program to document preferences between Zubsolv and Suboxone in patients who are being treated with Suboxone. In addition, Orexo is implementing a clinical program that is designed to show that opioid-dependent patients can be treated with Zubsolv from the first day that physicians choose to prescribe a buprenorphine-based therapy. This is contrary to the labeled indication for Suboxone, which states that patients have to be started on a different buprenorphine product before conversion to Suboxone.

Orexo is planning to launch Zubsolv in the U.S. during the third quarter of 2013.

During the first half of 2014, the company will add to the original two dosing strengths with further preformulated dosing options. Orexo has also initiated the development of a complementary product formulation that provides a taste alternative to the current lemon/menthol flavor of Zubsolv. Orexo projects that this product formulation will be ready for regulatory submission in late 2013 and will be introduced to the U.S. market during the second half of 2014.

For more information, visit the Orexo Web site.

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