August 20, 2023

FDA Approves Second OTC Naloxone Nasal Spray for Opioid Overdose

The FDA approved RiVive (naloxone hydrochloride) nasal spray for over-the-counter (OTC), nonprescription use for the emergency treatment of known or suspected opioid overdose.

This is the second nonprescription naloxone product the agency has approved, helping increase consumer access to naloxone without a prescription. The timeline for availability and the price of this nonprescription product will be determined by the manufacturer.

Opioid pain medications are commonly used in workers’ comp, and even when used responsibly, opioids come with various risks, including potential overdose.

Certain high-dose opioids are sometimes co-prescribed with naloxone medications in the event of overdose. As the second OTC naloxone nasal spray available without a prescription, individuals will soon have even greater access to naloxone, making it more likely that workers’ comp patients will obtain the drug.

Individual patients with heightened risks of opioid overdose may also be prescribed naloxone.

The approval of RiVive nasal spray for nonprescription use was supported by data from a study submitted by the manufacturer that showed similar levels of RiVive reach the bloodstream as an approved prescription naloxone product.

The drug has been demonstrated to be safe and effective for use as directed in its labeling. The manufacturer also provided data that showed consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional.

The use of RiVive nasal spray in individuals who are dependent on opioids may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.

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