PEOPLE: FDA Approves Naloxone Nasal Spray For Over-the-Counter Nonprescription Sales for The First Time To Reverse Opioid Overdoses
AGN.News Team
March 29, 2023
SILVER SPRING, MD (AGN.News) – Today, the Food and Drug Administration, a federal agency of the Department of Health and Human Services, announced the availability of Naloxone, a life-saving drug, will become available for over-the-counter sales by late summer 2023.
Naloxone or Narcan, as it is called, is a prescription drug that reverses opioid overdoses. Later this year, Narcan will soon be available for over-the-counter (OTC) sales without a prescription.
Pre-packaged Narcan will be available for retail sales in local big box chain stores, vending machines, supermarkets, neighborhood convenience stores, local gas stations and online retailers.
Press release from the FDA Commissioner
FDA Commissioner, Dr. Robert M. Califf, M.D., said in a statement that the over-the-counter authorization was meant to address a “dire public health need.”
FDA Commissioner Dr. Califf said, “Today’s approval of over-the-counter (OTC) naloxone nasal 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.”
For the past several years, there have been over 100,000 overdose deaths in the United States from opioid overdoses. Narcan, a nasal spray, will increase the number of locations where people can purchase it so more people can help save lives.
How does Naloxone save lives?
Naloxone, a non-addictive, life-saving drug is sold under the brand name Narcan among others. It is a nasal spray version of Naloxone. This Narcan drug blocks an opioid’s effect on the brain. It has saved thousands of lives all across the country since 2015.
Narcan is commonly used to counter decreased breathing in opioid overdoses. It begins to take effect within two minutes when given intravenously, and within five minutes when injected into a muscle. These methods are used within a clinical environment by medical professionals.
However, this announcement today opens the door for ordinary citizens to use Narcan as a nasal spray. This medicine can be administered in a non-clinical environment by spraying it into a person’s nose.
Naloxone or Narcan commonly blocks the effects of opioids for 30 to 90 minutes. In outsize cases, multiple doses may be required, as the duration of action of some opioids is greater than that of Narcan.
Opioid overdoses are a national problem
According to the Centers For Disease Control and Prevention in recent years there have been over 100,000 overdose deaths in the United States. In 2020, several US states had more than 3,000 deaths due to opioid overdoses.
Heroin overdose deaths is taking the lives of people all over America. Alone and in crisis fully describes many people’s daily lives. Many deaths are related to fentanyl and heroin. Fentanyl is more potent than heroin and kills the host within minutes.
Today, all street drugs sold are laced with fentanyl. It’s a synthetic opioid and used by street dealers to increase the “high” of the person. Before an addict knows it they’re in crisis and in need of intervention. Narcan, administered quickly, can save these lives.
America consumes 80% of the world’s opioids even though the US is only 4 or 5 percent of the world’s population. In many communities, White Americans between 24 and 35 years old are largely experiencing the highest percentage of overdose deaths.
In the US, Hispanic Americans account for 5 percent of the opioid deaths; African Americans account for 15 percent of opioid deaths; and White Americans account for 80 percent of opioid overdose deaths.
Opioid overdose deaths: An epidemic!
In 2020, there were only two US states that had less than 100 deaths from opioids overdoses, South Dakota and Wyoming. This was largely due to their much smaller populations. No state had zero deaths!
For example, in Tennessee, over 3,000 deaths; in Texas, over 4,000 deaths; in New York over 4,000 deaths; in Pennsylvania and Ohio, over 5,000 deaths; in Florida over 7,000 deaths; and in California over 8,000 deaths. The death-rates were higher in states with larger populations.
Federal action needed to save lives
Therefore, with over 101,000 US deaths in the 12 months ending October 2022, deaths from mostly synthetic drugs like fentanyl, mandated more federal solutions.
Since overdose deaths is a nationwide problem, a crisis, the federal government has added another workable program, at the community level, to address this US opioid crisis of overdose deaths.
FDA Commissioner Dr. Califf, M.D., added, “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.”
The FDA Commissioner addressed Narcan cost, “We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”
Use requires following FDA guidelines
Naloxone was first made available in 2015 as a prescription drug. The manufacturer provided data to prove naloxone is safe and effective for use as directed in its proposed labeling. Use of this drug requires the user to follow the FDA approved guidelines on the label for use.
The manufacturer also showed that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional.
“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,” said Patricia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.
She added, “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…”
Naloxone nasal spray was approved for marketing without a prescription last month, February 2023 and will be available for OTC sales in just a few months.
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