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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

    • Quotes

    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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    Orexo announces FDA acceptance of New Drug Application filing for OX124, a high-dose rescue medication for opioid overdose

    · OX124 is based on Orexo´s world-class drug delivery platform, amorphOX®, and is designed to reverse the effects of the most powerful synthetic opioids, such as fentanyl · Synthetic opioids are behind 91 percent of all fatal opioid overdoses in the US[1] · Prescription Drug User Fee Act date (PDUFA) set to July 15, 2024. If approved, US launch is expected to be initiated late 2024.   Uppsala, Sweden – November 28, 2023 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), today announces the New Drug Application (NDA) for OX124 has been accepted for review by the US Food and Drug

    Orexo shares new timeline for the high-dose rescue medication for opioid overdose, OX124

    Uppsala, Sweden – April 3, 2023 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), today announces the expected US launch of OX124, a high-dose rescue medication for opioid overdose, is delayed to late 2024 from previously first half of 2024, if approved by the US Food and Drug Administration (FDA) according to their ordinary timelines.   The updated timeline follows unexpected technical issues with the equipment used for the secondary packaging process in the outsourced supply chain for OX124 and there is a need for qualification and documentation of the packaging process to meet the

    Orexo announces positive results from pivotal trial for its leading pharmaceutical pipeline asset OX124

    · The pivotal trial OX124-002 meets the primary endpoints in the 4-period crossover, comparative bioavailability study in healthy volunteers · OX124 showed a significantly faster and higher absorption of naloxone compared to intramuscular dosing with the injection reference product · OX124 is designed to help in the fight against overdoses caused by the most powerful synthetic opioids that are behind the vast majority of fatal overdoses in the US · Upon approval Orexo will, along with ZUBSOLV® and MODIA™, have the most comprehensive range of treatment options for people suffering

    Orexo strengthens IP rights for overdose rescue drug OX124

    · Patent protection until 2039 · Previous human pharmacokinetic (PK) study showed significantly better PK profile when compared to market leading product Uppsala, Sweden – January 27, 2021 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY) today announces that the company has further strengthened the intellectual property (IP) for its flagship pharmaceutical pipeline asset OX124, a naloxone rescue medication for the treatment of opioid overdose. The US Patent and Trademark Office (USPTO) has issued a new patent protecting the product until 2039. The new patent, US 10,898,480, is the

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