The opioid crisis has become a major public health concern in the United States, with opioids being the main cause of drug overdose deaths in 2020, according to the Centers for Disease Control and Prevention. In an effort to address this dire public health need, the Food and Drug Administration (FDA) has approved the first Over-the-counter nasal spray that rapidly reverses the effects of an opioid overdose. Narcan, a 4-milligram naloxone hydrochloride nasal spray, will be available without a prescription in supermarkets, convenience and drug stores, gas stations, vending machines and online.
Narcan blocks the effect that opioids have on the nervous system and reverses fatal overdoses. In the case of an opioid overdose, two nasal spray devices typically come in a single package and the first Narcan dose should be administered before 911 is called. The person should get the second dose immediately after two to three minutes goes by and they are still unresponsive.
The FDA has also encouraged the manufacturer to make the product quickly available and to keep it affordable. Patrizia Cavazzoni, MD, director of the FDA Center for Drug Evaluation and Research, said that the FDA would work with stakeholders to ensure ongoing access to all forms of Naloxone during the transition. The FDA has also made it easier for drug companies to sell discounted Naloxone to harm reduction groups, allowing an umbrella organization to purchase and ship 768,000 more vials.
The Biden administration has allocated money to local health departments to buy the antidote and has seen a decline or flattening of overdose deaths for seven months in a row. Walgreens has also said it will offer nonprescription Narcan nationwide both in-store and online. Furthermore, the American Medical Association has urged all manufacturers of naloxone to seek over-the-counter approvals in the hopes that the drug is covered at little or no cost to consumers.
The FDA approval of the over-the-counter version of Narcan could save lives, while also providing greater access to the lifesaving drug. This could potentially lead to lower prices of generic Naloxone sprays and make it easier for people to obtain the medication. It is a crucial step towards addressing the opioid crisis and a step towards saving lives.