The U.S. Food and Drug Administration approved Harm Reduction Therapeutics’ RiVive, 3 milligram naloxone hydrochloride nasal spray for over-the-counter or OTC, nonprescription use for the emergency treatment of known or suspected opioid overdose.
The agency’s second nonprescription naloxone product approval is expected to help increase consumer access to naloxone without a prescription.
The manufacturer will take the decision on the timeline for availability and the price of the nonprescription product.
In the U.S., drug overdose remains a major public health issue, and more than 105,000 reported fatal overdoses occurred in a year till February 2023. These were primarily driven by synthetic opioids like illicit fentanyl.
Naloxone, the standard treatment for opioid overdose, is a medication that rapidly reverses the effects of opioid overdose.
The FDA’s latest approval of RiVive nasal spray for nonprescription use was based on data from a study submitted by Harm Reduction. The study showed similar levels of RiVive reach the bloodstream as an approved prescription naloxone product. The results showed the drug to be safe and effective for use as directed in its labeling.
The company’s data also showed consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional.
According to the agency, RiVive nasal spray’s use in those who are dependent on opioids may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate, fever, shivering or trembling, abdominal cramps, weakness and increased blood pressure, among others.
FDA Commissioner Robert Califf, said, “We know naloxone is a powerful tool to help quickly reverse the effects of opioids during an overdose. Ensuring naloxone is widely available, especially as an approved OTC product, makes a critical tool available to help protect public health.”
The agency approved the first nonprescription naloxone nasal spray product in March 2023, while the first generic nonprescription naloxone nasal spray product was approved in July 2023. Over the last year, it has undertaken new efforts to expand opioid disposal options.
The FDA further welcomed manufacturers of other naloxone products to discuss potential nonprescription development programs.
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