FDA Declines to Approve OX124 Nasal Spray for Opioid Overdose Treatment
The US Food and Drug Administration (FDA) has again declined Swedish drug manufacturer Orexo’s New Drug Application (NDA) for OX124, a high-dose naloxone nasal spray for opioid overdose reversal, citing the need for an additional Human Factor study as well as additional technical data on the final commercial product.
“We remain confident our powerful life-saving medication, OX124, can contribute to reducing the steep number of Americans who die from overdoses caused by the increasingly prevalent synthetic opioids, “said Nikolaj Sørensen, President and CEO of Orexo, in a press release. “Me and my team are determined to continue taking the necessary actions to swiftly provide the FDA with the additional information.”
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Notably, the FDA did not request additional clinical trial data. Rather, regulators desire further data demonstrating that patients who attain OX125 can administer the medication correctly.
Orexo’s OX124 is a high-dose formulation of naloxone reformulated using its “proprietary powder-based platform, AmorphOX.” The resultant investigational drug is a “rapidly absorbed, highly stable, and highly bioavailable” opioid overdose reversal agent. The company notes that the nasal spray will “meet the growing need for more powerful medications and higher doses of naloxone” to counteract the effects of synthetic opioids, including fentanyl and fentanyl analogues.
The FDA previously rejected OX124 in April 2023, citing “technical issues with the equipment used for the secondary packaging process” in its Complete Response Letter.
Orexo estimated that once the NDA is resubmitted, the review period will take up to 6 months.
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