Orexo submits NDA for nasal opioid overdose rescue drug

Feb. 7, 2023

Swedish drugmaker Orezo AB announced this week that it has submitted a New Drug Application to the FDA for its opioid overdose nasal rescue medication, OX124.

The company's lead pipeline asset, OX124 is formulated using the Orezo’s proprietary drug delivery platform amorphOX and a high dose of naloxone. AmorphOX is a powder-based technology that is physically and chemically stable — even when stored in elevated temperatures — and made of a combination of f a drug, carrier materials, and, optionally, other excipients such as a permeability enhancer.

Orexo is supporting the NDA with results from the OX124-002 study, where the drug demonstrated having a faster and higher absorption of naloxone when compared to intramuscular dosing. Earlier studies also showed that the drug had higher bioavailability when compared with market-leading medication. 

According to Orexo, the switch to highly potent synthetic opioids has led to more severe overdoses, prompting the need for high-dose naloxone products. If OX124 is approved, the drugmaker is planning to initiate a U.S. launch during the first half of 2024.

Back in 2013, the FDA approved Orexo’s Zubsolv for the treatment of opioid addiction. The drug, offered in a sublingual tablet, combines buprenorphine and naloxone.