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

The type of technical data required by FDA has already been generated from our pilot scale manufacturing and the data were included in the NDA. Orexo´s assessment is that the submitted data support approval however, FDA does not agree and has requested data from the established commercial scale manufacturing. The type of technical data required by FDA has already been generated from our pilot scale manufacturing and the data were included in the NDA. Orexo´s assessment is that the submitted...

Sweden, 16/07/2024 (informazione.it - comunicati stampa - salute e benessere)

The type of technical data required by FDA has already been generated from our pilot scale manufacturing and the data were included in the NDA. Orexo´s assessment is that the submitted data support approval however, FDA does not agree and has requested data from the established commercial scale manufacturing.

Upon approval OX124 will meet the growing need for more powerful medications and higher doses of naloxone for reversal of opioid overdoses involving synthetic opioids, such as fentanyl or fentanyl analogues, which today cause 92 percent of all fatal opioid overdoses.  OX124 is a high dose proprietary naloxone formulation and, as a result of rapid absorption and high bioavailability, can reverse an overdose or sustaining consciousness in a patient who has taken synthetic opioids.

Nikolaj Sørensen, President and CEO
Lena Wange , IR & Communications Director

+46 (0)18 780 88 00

Orexo is a Swedish pharmaceutical company with over 25 years of experience developing improved pharmaceuticals based on proprietary formulation technologies that meet large medical needs. On the US market, Orexo provides innovative treatment solutions for patients suffering from opioid use disorder and adjacent diseases. Products targeting other therapeutic areas are developed and commercialized worldwide with leading partners. Total net sales in 2023 amounted to SEK 639 million , and the number of employees to 116. Orexo is listed on Nasdaq Stockholm's main list and is available as an ADR on OTCQX (ORXOY) in the US.

For more information about Orexo please visit, www.orexo.com . You can also follow Orexo on
X, LinkedIn, and YouTube.

This information is information that Orexo AB (publ.) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 8 pm CET on July 16 , 2024. 

Center of Disease Control and Prevention, predicted number of fatal overdoses ending Dec. 2023

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https://mb.cision.com/Main/694/4015773/2918762.pdf  Orexo shares new information on OX124_ July 16 2024

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