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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 shares new information on OX124, a high-dose naloxone rescue medication in development for opioid overdose

    Uppsala, Sweden – July 16, 2024 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), today announces that the company has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for OX124, a high-dose naloxone rescue medication in development for opioid overdose. The NDA was submitted to the FDA on September 18, 2023. The CRL indicates the need for an additional Human Factors (HF) study, which is in line with previous communication. Furthermore, additional technical data on the final commercial product has been requested. The

    Orexo submits New Drug Application to FDA for OX124, a high-dose rescue medication for opioid overdose

    · OX124 is designed to reverse the effects of the most powerful synthetic opioids, such as fentanyl · Nine out of ten fatal opioid overdoses in the US involve synthetic opioids · If approved, the US launch is expected to be initiated in H1 2024   Uppsala, Sweden – February 3, 2023 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), today announces the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its lead pharmaceutical pipeline asset, OX124, a nasal rescue medication for opioid overdose. OX124, is based on Orexo´s drug delivery platform

    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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