Citing the need for another human factor study and more technical data for the final product, the FDA denied approval of Orexo’s nasal spray rescue medication for opioid overdose.
The FDA on Tuesday rejected Orexo’s application for OX124, its high-dose naloxone nasal spray for the rescue treatment for opioid overdose.
While the regulator’s Complete Response Letter (CRL) does not indicate a need for additional clinical and non-clinical studies, the FDA is requiring another “human factors” study before the company files another application. This request is “in line with previous communication,” Orexo noted in its news release, adding that it has already completed such a study.
The CRL also asked for additional technical data on the final commercial product, which Orexo said is “unexpected.” The company will work “expeditiously” with the FDA to address this requirement and resubmit a New Drug Application (NDA) “as soon as possible,” according to its announcement. Orexo expects the review of its resubmission to last up to six months.
“I am surprised with the agency’s other requests with regards to additional technical data from final commercial product,” Orexo president and CEO Nikolaj Sørensen said in a statement, adding that he is nevertheless “confident” that the company can address the FDA’s requests “efficiently.”
“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,” Sørensen added.
OX124 is Orexo’s investigational reformulation of naloxone, which was originally approved under the brand name Narcan. Naloxone is a well-known treatment for opioid overdoses and is currently available both as an injectable drug and as a nasal spray. The drug works by binding to the same receptors that opioids do, thus reversing the typical symptoms of overdose, such as respiratory depression, hypotension and sedation.
Orexo reformulated naloxone using its proprietary powder-based platform, AmorphOX. The investigational nasal spray delivers a specific formulation of naloxone that is rapidly absorbed, highly stable and highly bioavailable, according to Orexo’s press release accompanying the acceptance of OX124’s resubmitted NDA in November 2023.
The FDA had previously rejected OX124 in April 2023, citing “technical issues with the equipment used for the secondary packaging process,” Orexo said at the time.
The company contends that OX124 could play an important role in stemming the overdose epidemic that continues to plague the U.S. The Centers for Disease Control and Prevention reports that there were more than 107,000 drug overdose deaths in the country in 2023, of which nearly 82,000 were attributed to synthetic opioids such as fentanyl.
