Research & Development
Orexo's OX124 New Drug Application accepted for review by US Food and Drug Administration
29 November 2023 -

Orexo AB (STO: ORX) (OTCQX: ORXOY), a Sweden-based pharmaceutical company, announced on Tuesday that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for review of OX124.

OX124 is a nasal rescue medication for opioid overdose containing a high dose of naloxone and is the first product based on Orexo´s drug delivery platform, amorphOX. The Prescription Drug User Fee Act (PDUFA) date is set to 15 July 2024, but recent review processes in the category indicate a risk of some delay.

OX124 is a potent medication and, in combination with rapid absorption and high bioavailability, this makes it capable of reversing an overdose or sustaining consciousness in a patient who has taken synthetic opioids.

It is an innovative powder-based technology that improves stability and reduces sensitivity related to temperature changes in addition to rapid absorption and high bioavailability.