FDA to Assess Potent Opioid Overdose Rescue Med

The New Drug Application (NDA) for OX124, designed to address opioid overdose, has been acknowledged by the Food and Drug Administration (FDA) for evaluation.

OX124 is an intranasal medication featuring a substantial dose of naloxone, an opioid antagonist recognized for reversing opioid-induced effects like respiratory depression, sedation, and hypotension. Utilizing Orexo's exclusive technology, OX124 aims to counteract overdoses from potent synthetic opioids, such as fentanyl.

The NDA submission encompasses data from a clinical study indicating that OX124, when administered to healthy volunteers, results in notably quicker and higher naloxone absorption compared to intramuscular injection of another naloxone product.

The President and CEO of Orexo expressed optimism, stating, "With its elevated naloxone dosage and unique formulation, OX124 holds the potential to mitigate the rise in fatal overdoses linked to the widespread misuse of synthetic opioids." Anticipating approval, the company plans to commence commercial activities in the second half of 2024, focusing on reimbursement before a broader rollout to retail pharmacies in early 2025.

A Prescription User Fee Act date of July 15, 2024, has been established for the application, although the company acknowledges the possibility of regulatory decision delays.

Earlier, the settlement between OxyContin manufacturer Purdue Pharma and numerous opioid crisis-related lawsuits, offering up to $6 billion to combat the epidemic, faced scrutiny. The deal, releasing Purdue from control and shielding the Sackler family from civil lawsuits, was contested as the Supreme Court assessed its compliance with federal law. The moral dilemma emerged as victims, despite potential compensation, question the exoneration of the wealthy Sacklers who could retain OxyContin profits.

The 1996 aggressive marketing of OxyContin by Purdue Pharma is linked to the opioid epidemic, with the settlement allocating funds for opioid abatement and victim compensation. While some victims initially supported the deal, concerns arise about closure, emphasizing that money may not address the profound impact of the crisis. Lawyers acknowledge the settlement as significant but recognized its limitations in fully compensating for OxyContin's harm.

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