Orexo

Orexo
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About Us

Orexo develops improved pharmaceuticals and digital therapies addressing unmet needs within the growing space of substance use disorders and mental health. The products are commercialized by Orexo in the US or via partners worldwide. The main market today is the American market for buprenorphine/naloxone products, where Orexo commercializes its lead product ZUBSOLV® for treatment of opioid use disorder. Total net sales for 2021 amounted to SEK 565 million and the number of employees was 121. Orexo is listed on the Nasdaq Stockholm Mid Cap (ORX) and is available as ADRs on OTCQX (ORXOY) in the US. The company is headquartered in Uppsala, Sweden, where research and development activities are performed. For more information about Orexo please visit, www.orexo.com. You can also follow Orexo on Twitter, @orexoabpubl, LinkedIn and YouTube.

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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
info@orexo.se

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

Fri, Feb 03, 2023 08:00 CET

· 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

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

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