FDA Approves First OTC Naloxone Nasal Spray
The FDA approved Narcan (naloxone hydrochloride) 4mg nasal spray for over-the-counter (OTC) use – the first naloxone product approved for use without a prescription. Naloxone rapidly reverses the effects of opioids and is the standard treatment for opioid overdose. As opioid pain medications are commonly used in workers’ comp and come with risk of overdose even when used properly, this approval makes this life-saving drug more accessible for injured worker patients. The approval may also affect the status of other brand-name naloxone nasal spray products of 4 mg or less, but determinations will be made on a case-by-case basis and the FDA may contact other firms as needed.
FDA Hopes to Make Naloxone Available Over the Counter
The FDA issued a Federal Register notice that assessed the safety and effectiveness of certain naloxone hydrochloride products for nonprescription use, hoping to make the opioid overdose reversal agent more accessible to the public. The preliminary assessment is intended to facilitate development and approval of nonprescription naloxone products. The FDA is continuing to collect data, such as product-specific data on non-prescription user interface design, including packaging and labeling. The notice requests comments from the public on whether there is data to support safe and effective nonprescription use of higher dose naloxone products and on potential consequences of a switch from prescription to nonprescription status.