breaking latest news – The US drug regulator has announced that the Narcan, the treatment that reverses overdoses, can be distributed without a prescription, a move that comes as the country battles an acute opioid addiction crisis. The Federal Drug Administration (FDA) has stated that the doses of spray nasally four milligrams of naloxone hydrochloride, the generic name for Narcan, can be sold over the counter virtually anywhere, from pharmacies to supermarkets to gas stations.
The FDA says it has moved to address the growing number of victims of opioid use, particularly the relatively easy-to-make, synthetic fentanyl, which has increasingly replaced heroin and prescription painkillers such as heroin over the past five years. main drug used by people addicted to opioids. In the 12 months to October 2022, the United States recorded 101,750 overdose deaths, largely due to fentanyl, the FDA said in a statement.
“The agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development and approval of an over-the-counter naloxone product to address a critical public health need,” said FDA Commissioner Robert Califf. Narcan, by far the most widely used version of naloxone, can quickly reverse the effects of an overdose.
Narcan “brings someone back from the dead,” Johnny Bailey, who has recovered from an opioid addiction and trains people to administer the drug, explained in early March in Washington. Previously administered primarily by injection, Narcan, manufactured by Emergent BioSolutions, was approved as a prescription drug in its nasal spray form in 2015.
With the number of overdoses rising each year, the FDA accelerated its review of over-the-counter Narcan earlier this year. The FDA said other naloxone spray manufacturers may get approval on a case-by-case basis. “Naloxone is a critical tool in addressing opioid overdoses,” said Patrizia Cavazzoni, the FDA’s head of drug evaluation.
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