Orexo announced that it has submitted an NDA for its OX124 intranasal naloxone for the reversal of opioid overdose. The company notes that FDA review is likely to take a little more than a year and says that it is planning for a launch in the first half of 2024.
OX124 is based on the company’s amorphOX particle engineering technology, which also underlies its OX125 intranasal nalmefene and OX140 intranasal epinephrine. According to Orexo, OX124 is covered by patents through 2039.
Orexo President and CEO Nikolaj Sørensen commented, “With the filing of OX124 we are now one step closer to bringing this important product to market, providing this life-saving medication to the stigmatized and underserved patient group with opioid use disorder.”
Read the Orexo press release.
