Orexo said that the FDA has accepted the company’s NDA for OX124 intranasal dry powder high dose naloxone for the reversal of opioid overdose and has set a PDUFA date of July 15, 2024. The company initially announced that it had submitted an NDA for OX124 in February 2023; however, the FDA rejected that application, requesting additional information about the packaging process. Orexo resubmitted the NDA in September 2023.
OX124 is based on the company’s amorphOX nasal powder technology. Orexo is developing two other intranasal products based on the amorphOX technology: OX125 nalmefene and OX640 adrenaline.
Orexo President and CEO Nikolaj Sørensen 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 commercialization 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.”
Read the Orexo press release.
