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  • Orexo
    Box 303 751 05 Uppsala
    +46 (0)18 780 88 00
    +46 (0)18 780 88 88
    http://www.orexo.com

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    With the acquisition of the rights to two digital health products from GAIA and the appointment of Dennis, a thought leader in the digital health industry in the US, we are well positioned to lead this development within the complementary disease areas of our pharmaceutical business.
    Nikolaj Sørensen, President and CEO
    Our strategy is to focus on solutions with scientifically proven therapeutic effect which will benefit the healthcare system as a whole and more importantly patients.
    Nikolaj Sørensen, CEO, about Digital Therapies
    I am convinced that DTx will become an integral and natural part of addiction treatment in the future. This digital therapy for OUD patients is perfectly positioned with Orexo’s competences and commercial organization in the US.
    Nikolaj Sørensen, President and CEO
    Mundipharma Australia has been a good partner in the approval process and we are confident that their experience and infrastructure will create a strong foundation for a successful launch of Zubsolv®
    Nikolaj Sørensen, President and CEO
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    New regulations will expand access to treatment of opioid dependence in the US

    Uppsala, Sweden – September 18, 2015 – Orexo AB (publ) informs, that yesterday the United States Department of Health and Human Services (HHS) Secretary Sylvia M. Burwell announced important steps to increase access to the treatment of opioid dependence in the US. According to HHS, overdoses from prescription opioid pain relievers claimed more than 16,200 lives in 2013. “The opioid epidemic knows no boundaries; it touches lives in cities, rural counties and suburban neighborhoods across the country,” said Secretary Burwell. The resulting health, social, and economic consequences for

    U.S. FDA Approves ZUBSOLV® for Induction of Buprenorphine Maintenance Therapy in Patients Suffering from Opioid Dependence

    Uppsala, Sweden – August 11, 2015 - Orexo AB (publ) announced today that the U.S. Food and Drug Administration (FDA) has approved ZUBSOLV® (buprenorphine/naloxone CIII sublingual tablet) for induction of buprenorphine maintenance therapy in patients with opioid dependence. The approval expands on the current indication for ZUBSOLV, originally approved by the U.S. FDA on July 3, 2013, and is based on data from two Phase III studies demonstrating ZUBSOLV as a an effective treatment for opioid dependence with a solid safety profile. Induction is the initial process a physician performs when a

    FDA approves the medium tablet strength, 2.9 mg/0.71 mg, of ZUBSOLV®

    Uppsala, Sweden – June 10, 2015 – Orexo AB (publ) announces today that it has received approval from the U.S. Food and Drug Administration (FDA) of medium dosage strength of ZUBSOLV® (buprenorphine/naloxone CIII sublingual tablet) for maintenance treatment of opioid dependence. The new dosage strength is 2.9 mg/0.71 mg buprenorphine/naloxone CIII sublingual tablets. The new 2.9 mg/0.71 mg dosage strength is expected to be launched during second half of 2015. The new dosage strength complements the existing strengths of 1.4 mg/0.36 mg, 5.7 mg/1.4 mg, 8.6 mg/2.1 mg and 11.4 mg/2.9 mg

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