Last Updated on July 19, 2024 by The Health Master
Nasal Spray
Nasal Spray: Opioid overdose remains a critical public health concern in the United States. Naloxone, a medication that can reverse opioid overdose effects, is a crucial tool for saving lives.
Orexo AB, a Swedish pharmaceutical company, recently faced a hurdle in its efforts to introduce a new high-dose naloxone nasal spray called OX124.
USFDA Requests Additional Information
On July 16, 2024, Orexo announced that the U.S. Food and Drug Administration (USFDA) had not approved OX124.
The USFDA issued a complete response letter (CRL) requesting further information from Orexo.
This letter outlined two key requirements for resubmission:
- Additional Human Factors (HF) Study: The USFDA seeks a new study to evaluate how users interact with the OX124 nasal spray packaging and instructions. This ensures clear and easy administration during a potential overdose emergency.
- Technical Data on Final Commercial Product: Orexo needs to provide additional technical data specific to the final commercially available version of OX124. This data likely pertains to the manufacturing process or final product formulation.
Unexpected Request for Additional Data
Orexo expressed surprise regarding the request for extra technical data.
The company plans to collaborate with the USFDA to address the requirements and resubmit the marketing application for OX124.
Competitive Landscape of Naloxone Products
Several pharmaceutical companies currently offer naloxone products for opioid overdose reversal.
Here’s a quick comparison:
- Emergent BioSolutions’ Narcan: This nasal spray is USFDA-approved for over-the-counter (OTC) sale, making it readily accessible without a prescription.
- Harm Reduction Therapeutics’ RiVive: This prescription-free naloxone nasal spray offers another option for individuals at risk of opioid overdose.
- Walgreens Boots Alliance’s Naloxone Auto-Injector: This recently launched option provides an alternative delivery method compared to nasal sprays. It’s available OTC at Walgreens pharmacies for a retail price of $34.99 per pack (containing two 4mg doses).
Looking Ahead for Orexo’s OX124
The USFDA’s request for additional studies delays the potential launch of OX124.
While the high-dose formulation might offer benefits in certain overdose situations, Orexo must first address the USFDA’s concerns regarding user experience and technical data.
This development highlights the ongoing efforts to improve access to effective naloxone products for combating the opioid overdose crisis.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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