FDA accepts new drug application for Orexo’s opioid overdose medication
Betsy Goodfellow | November 28, 2023 | News story | Research and Development | FDA, Opioid overdose, Pharmacy, opioids, orexo
Orexo has announced that its New Drug Application (NDA) for OX124 has been accepted for review by the US Food and Drug Administration (FDA) as a nasal rescue medication for opioid overdose.
The drug contains a high dose of naloxone and has been designed on Orexo’s drug delivery platform, amorphOX. This platform is an “innovative powder-based technology that, in addition to rapid absorption and high bioavailability, improves stability and reduces sensitivity related to temperature changes,” according to the company’s press release.
The drug’s Prescription Drug User Fee Act (PDUFA) date is currently 15 July 2024, however it is expected that there may be some delays suggested by recent review processes in this category.
Nikolaj Sørensen, president and CEO of Orexo, commented: “I am pleased the FDA can now start reviewing our rescue drug, OX124. With its high-dose of naloxone and unique formulation, OX124 has the potential to reduce the acceleration in fatal overdoses caused by the widespread misuse of synthetic opioids. We’re approaching this launch in a rapidly growing market that’s currently undergoing major changes, which are closely monitored by me and my commercialisation team in the US. I feel confident we can take advantage of these recent developments to reach many people acutely in need of more powerful overdose rescue medications. With approval, we intend to initiate commercial activities during the second half of 2024 with a focus on obtaining reimbursement ahead of a broader launch into retail pharmacies early in 2025.”
Betsy Goodfellow
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