Research & Development
Orexo AB submits OX124 New Drug Application to FDA
19 September 2023 -

Orexo AB (publ.) (STO: ORX) (OTCQX: ORXOY), a Sweden-based pharmaceutical company, announced on Monday that it has submitted the New Drug Application (NDA) to the US Food and Drug Administration (FDA) for OX124, a high-dose rescue medication for opioid overdose with nasal delivery.

OX124 is based on the company's amorphOX and is designed to reverse the impacts of the most powerful synthetic opioids, such as fentanyl.

The company says that it has submitted the NDA based on the data from a pivotal study in healthy volunteers, OX124-002, where OX124 indicated a significantly faster and higher absorption of naloxone compared to intramuscular dosing with an injection reference product. The company adds that OX124's development formulations of in an exploratory clinical study (OX124-001) in healthy volunteers, indicated a more rapid absorption and higher bioavailability compared with the market leading naloxone rescue medication, even with the same dose as the comparator.

OX124 is protected by patents until 2039.

Orexo stated that if the product is approved, it will meet the significant and increasing requirement of more powerful rescue medications, improving the possibility of reviving individuals who have received an overdose caused by use of synthetic opioids, such as fentanyl.