FDA Wants To Make Opioid Overdose Antidote Accessible To Many People
The life-saving drug that reverses an overdose of opioids could soon become readily accessible to everyone.
The U.S. Food and Drug Administration (FDA) recently held a joint meeting between the Nonprescription Drug Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss the supplemental new drug application for Narcan nasal spray.
Emergent BioSolutions Inc. proposed to allow the nonprescription application of Narcan. At the meeting, the committees unanimously voted in favor of it, so the spray could become available over the counter, giving access to more people in need of the antidote.
Though the final decision is all up to FDA Commissioner Dr. Robert Califf, the federal agency has already voiced its desire to expedite the nonprescription version of naloxone, the generic name for Narcan.
The FDA has even advised the industry to change the label of the spray and include simple directions for use, so the general public would know how to use it. The agency also suggested including instructions to call 911 after drug administration, as per CNN.
Once Califf approves the proposal, the nasal spray version of Narcan could be sold across the country via grocery stores, gas stations, big box stores and even vending machines.
Committee member Dr. Brian Bateman said this is a monumental step in addressing the country’s ongoing opioid crisis. He noted making it accessible to more people could also decrease the stigma surrounding the antidote.
“This is a very important step from the cultural perspective. A key component of our addressing the ongoing opioid crisis will be broadening community access to this medication and decreasing the stigma associated with the purchase of naloxone. We know from long experience that this is a safe and effective medication,” he was quoted as saying by CNN.
Naloxone is effective against overdoses due to heroin, fentanyl and prescription opioid medications. It quickly reverses an overdose by blocking the effects of opioids. It can restore normal breathing within a few minutes of opioid overdose, according to the Centers for Disease Control and Prevention (CDC).
The Narcan nasal spray is already available as a prescription drug across the country. Meanwhile, naloxone can be purchased at pharmacies without a prescription in most states. Nevertheless, many people do not know how to use it. So the FDA wants a product that is accessible and easy to use for everyone who may need it.
“We believe that removing the prescription status of naloxone will allow for many emergency departments, health clinics, colleges, universities, high school and physician offices to better distribute naloxone,” Dr. Bobby Mukkamala, the immediate past chair of the American Medical Association board, told CNN.