FDA approves nonprescription nasal spray for opioid overdose
Click Here to Manage Email Alerts
The FDA today announced the approval of an over-the-counter, nonprescription RiVive (naloxone hydrochloride) nasal spray for emergency treatment of opioid overdose, according to a press release.
The product was approved at a dose of 3 mg.
“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,” FDA Commissioner Robert M. Califf, MD, said in the statement. “The agency has long prioritized access to naloxone products, and we welcome manufacturers of other naloxone products to discuss potential nonprescription development programs with the FDA.”
RiVive is the second nonprescription naloxone product approved by the FDA. Previous data have shown that naloxone hydrochloride can be used safely by consumers without the supervision of a health care professional.
The nonprescription nasal spray’s availability and price will be determined by the manufacturer.