WASHINGTON, DC – March 29, 2023 – On March 29th, the U.S. Food and Drug Administration (FDA) approved selling the opioid overdose-reversing drug naloxone (trade name Narcan) without a prescription. This can improve access to a life-saving medicine in an effort to reduce the number of deaths from drug overdose. The over-the-counter (OTC) form will be available by the end of the summer. Manufacturers of generic versions will have to file separate applications to the FDA requesting OTC status.
Narcan is a nasal spray and the most popular form of naloxone. It is manufactured by Emergent BioSolutions, a U.S. pharmaceutical company. The U.S. opioid crisis has resulted in more than 100 thousand overdose deaths a year between October 2021 to October 2022 (according to CDC data). A majority of these deaths are linked to fentanyl, a very potent synthetic opioid. Naloxone can reverse opioid overdoses, of street drugs (heroin, fentanyl) and prescription medicine (oxycodone).
Harm reduction can reduce the risks that may be associated with drug use practices and offer support options. Community-based naloxone distribution is an important option for overdose prevention. Substance use advocates have been recommending that Narcan be available without prescription. Having this life-saving medicine available where people use drugs and where people are more likely to be around overdoses can reduce deaths.
Pharmacies have been allowed to sell naloxone without a prescription because of favorable standing order laws in every state in the U.S. including North Carolina. Consumers must ask the pharmacist for the medicine before buying it. In spite of these laws, Narcan has not been available at every retail pharmacy. This life-saving medicine is also available at local health departments, with first responders, and syringe service programs at little or no charge. Following the FDA action, Narcan could potentially be available at convenience stores, gas stations, supermarkets and online where other over-the-counter medicine are sold.
The new FDA ruling does not directly affect what manufactures and pharmacies charge for the medicine. A Narcan kit of 2 doses of nasal spray can cost from $50 to $143. Many insurances cover the cost; however, uninsured people would have to pay the full retail price.
FDA Commissioner Robert Califf said in a statement, “Today’s approval of OTC naloxone spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country.”
Listen to the full report below:
Contact: Dr. Dick Needleman, Health reporter, 103.3 AshevilleFM, email@example.com