Orexo shares new timeline for the high-dose rescue medication for opioid overdose, OX124
Orexo AB announces a delay in the US launch of OX124, a high-dose rescue medication for opioid overdose, pushing the anticipated date to late 2024 from early 2024. This shift is attributed to unforeseen technical issues with the secondary packaging process, requiring a resubmission of the New Drug Application (NDA) to the FDA. Despite the delay, the FDA has indicated that the request for resubmission is solely due to the packaging issues and not other concerns. Orexo aims to resubmit the NDA by Q3 2023, with hopes for approval in the latter half of 2024.
Nikolaj Sørensen, CEO, expressed disappointment over the delay but emphasized confidence in resolving the packaging issues.
- The FDA's request for resubmission is based solely on technical packaging issues, indicating no concerns with the drug's efficacy.
- Successful data from pivotal clinical studies support the NDA for OX124.
- The US launch of OX124 has been delayed to late 2024, impacting potential revenue timelines for Orexo.
- Technical issues in the packaging process may raise concerns regarding the reliability of the supply chain.
UPPSALA,
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 reliability requirements. As a result, FDA has requested
The request for a resubmission is solely based on the technical issues in the packaging process and no other concerns have been shared by the FDA.
and any potential issues are assessed in detail before initiating commercial manufacturing. I am disappointed with the delay in the process of bringing this life saving medication to the US market. However, I am pleased the manufacturing team is confident we have a solution to the technical issues in the packaging process and that it has no impact on the chances for final approval. When solved, this will even further strengthen the supply chain for our future rescue medications, such as OX640 and OX125."
On
For further information please contact:
Tel: +46 (0)18 780 88 00 | Tel: +46 (0)18 780 88 00 | ||
E-mail: ir@orexo.com | E-mail: ir@orexo.com |
About opioid overdose
Opioid overdose is a life-threatening condition, characterized by loss of consciousness and respiratory depression. Opioid overdoses can be treated with the opioid antagonist naloxone. During the 12-month period ending
About OX124-002
This pivotal trial was a 4-period cross-over, comparative bioavailability study in healthy volunteers, comparing two dose regimens of OX124 to two dose regimens of an injection reference product. The study met its primary endpoints with naloxone exposure within the targeted interval. In addition, it showed a significantly faster and higher absorption of naloxone compared to intramuscular dosing with the injection reference product. OX124 was also well tolerated.
About OX124-001
This study was a cross-over, comparative, bioavailability study comparing four development formulations of OX124 to the market leading naloxone rescue medication (4 mg) in the US.
All formulations of OX124 were well tolerated and showed substantially higher plasma concentrations of naloxone, sustained duration of elevated plasma concentrations, and equivalent or superior onset time versus the comparator.
About
For more information about
The information in the press release is information that
1 https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm. During the same period the predicted annual number of total fatal overdoses amounted to more than 107,000.
The following files are available for download:
Orexo_PR_Orexo shares updated timeline for high dose rescue medication OX124_Published | |
https://news.cision.com/orexo/i/ox124-device-red-l-vial,c3163309 | OX124 device Red L Vial |
View original content:https://www.prnewswire.com/news-releases/orexo-shares-new-timeline-for-the-high-dose-rescue-medication-for-opioid-overdose-ox124-301788020.html
SOURCE
FAQ
What is the new launch date for Orexo's OX124?
Why was the launch of OX124 delayed?
When does Orexo plan to resubmit the NDA for OX124?
What did Orexo's CEO say about the delay in OX124's launch?