NARCAN® Nasal Spray has been approved by the FDA as an over-the-counter treatment.
In February this blog reported on the public health crisis of opioid addiction and the dramatic spike in sudden deaths by overdose caused primarily by the widespread use of synthetic fentanyl.
FAMCare Blog - February 7, 2023
“Opioid addiction is here to stay,” said a social work professor we interviewed. “However, we do have treatment for this particular addiction. But as long as we turn away from the horrors of this widespread addiction and choose to remain in denial, we will not make a concerted effort to widely administer treatment. The pharmaceutical industry has already created both long term treatments and emergency life-saving medications that are simply not being administered on a wide enough scale. I believe that a nationwide effort to make these medications available to anyone trapped in this particular substance abuse disorder should be a number-one priority for the social work profession at large.”
Drug overdose persists as a major public health issue in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl.
FDA Commissioner Robert M. Califf, M.D. - August 2022
“In August 2022, I announced the FDA’s Overdose Prevention Framework – our expanded vision to undertake creative actions with an impact not only on preventing drug overdoses and reducing deaths from opioids and other substances, but also ameliorating the tremendous toll of addiction on American individuals and families. As part of that announcement, I shared that the agency would commission an independent study on opioid-related activities. The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need.
FDA Bulletin - February 2023
The application to approve Narcan nasal spray for OTC use was granted priority review status and was the subject of an advisory committee meeting where members voted unanimously to recommend it be approved for marketing without a prescription.
Public Health Bulletin - March 29, 2023
Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over the counter (OTC), nonprescription, use – the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. Today’s action paves the way for the life-saving medication to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online.
Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.
“Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis. The FDA is working with our federal partners to help ensure continued access to all forms of naloxone during the transition of this product from prescription status to nonprescription/OTC status. Further, we will work with any sponsor seeking to market a nonprescription naloxone product, including through an Rx to OTC switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions.”
Social Workers Communicate
Every home’s first aid kit should include NARCAN. This is the message the social work community has begun to communicate to the entire nation. This public health bulletin is not directed at known drug users or friends and family of those known to be abusing opioids. It is directed at every family in the country. “Naloxone has been around for a while but has failed to prevent thousands of deaths because the people who needed emergency access often didn’t know that it existed or where to get it. Many people are unaware that a loved one or a family member is abusing opioids and is at risk of overdose. These are just the people who need NARCAN in their medicine cabinet.”
Every home’s first aid kit should include NARCAN.
