US health authorities approved a new drug Friday to combat overdose deaths amid a persistent “major public health” crisis that claims hundreds of lives every day.
The US Food and Drug Administration approved RiVive, a naloxone hydrochloride nasal spray, for over-the-counter sales. RiVive is now the second overdose reversal drug to be approved for non-prescription use alongside Narcan.
In announcing its decision, the agency emphasized that overdoses remain “a major public health issue in the United States.” There were roughly 105,000 reported fatal overdoses during the 12-month period that concluded in February, according to official data.
Most have been linked to synthetic opioids like illicit fentanyl, an opiate several times stronger than heroin.
The FDA approved over-the-counter sales of Narcan in March.
“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 Califf said in a 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,” he added.
The FDA warned that the use of RiVive in individuals who are dependent on opioids “may result in severe opioid withdrawal,” which includes rapid heart rate, vomiting, sweating, shivering and abdominal cramps, among other effects.
Fentanyl is estimated to be between 50 to 100 times as powerful as morphine, and overdose deaths related to the synthetic opioid continue to rise. That includes a 56% increase from 2019 to 2020, according to the latest data from the US Centers for Disease Control and Prevention (CDC).
The CDC’s provisional data indicates that has further accelerated in the intervening years.