Nearly two years later, a long-awaited solution to the opioid crisis in the United States is now available: Narcan, a nasal spray that can quickly stop an opioid overdose, is freely available. The Food and Drug Administration's (FDA) approval of this change is the result of regulatory reforms called for by patient advocates and public health organizations.
This is an important step forward amid the nation's worsening opioid crisis. There are nearly 107,000 drug overdose deaths in the U.S. in 2021, up from about 92,000 in 2020 and about 70,600 in 2019. The leading cause of deaths was opioids, especially fentanyl, a synthetic drug much stronger than heroin that has become widespread in the drug trade over the past decade and has been one of the reasons for the rise in overdose deaths.
Narcan is the first-of-its-kind nasal form of naloxone, a drug used as an overdose rescue. It is very effective in quickly restoring breathing: it blocks the receptors in the brain that are affected by opioids, eliminating the dangerous slowing of breathing that can lead to death. The drug takes effect within two to three minutes of use.
According to a Reagan-Udoll Foundation report commissioned by the FDA, about 17 million doses of naloxone were distributed nationwide in 2021, marking a significant increase in the drug's availability since its introduction in 2015. Studies show that increased access to naloxone reduces opioid overdose deaths by more than 10 percent in regions where it has been made more widely available.
Despite progress, however, there are still challenges in the U.S. getting naloxone to those who need it most. According to the Centers for Disease Control and Prevention (CDC), nearly half of overdose deaths in 2021 occurred in the presence of another person who could have intervened. Public health organizations have long called for the co-prescribing of naloxone and prescription opioids, but such measures have so far been rarely used.
This is an important step forward amid the nation's worsening opioid crisis. There are nearly 107,000 drug overdose deaths in the U.S. in 2021, up from about 92,000 in 2020 and about 70,600 in 2019. The leading cause of deaths was opioids, especially fentanyl, a synthetic drug much stronger than heroin that has become widespread in the drug trade over the past decade and has been one of the reasons for the rise in overdose deaths.
Narcan is the first-of-its-kind nasal form of naloxone, a drug used as an overdose rescue. It is very effective in quickly restoring breathing: it blocks the receptors in the brain that are affected by opioids, eliminating the dangerous slowing of breathing that can lead to death. The drug takes effect within two to three minutes of use.
According to a Reagan-Udoll Foundation report commissioned by the FDA, about 17 million doses of naloxone were distributed nationwide in 2021, marking a significant increase in the drug's availability since its introduction in 2015. Studies show that increased access to naloxone reduces opioid overdose deaths by more than 10 percent in regions where it has been made more widely available.
Despite progress, however, there are still challenges in the U.S. getting naloxone to those who need it most. According to the Centers for Disease Control and Prevention (CDC), nearly half of overdose deaths in 2021 occurred in the presence of another person who could have intervened. Public health organizations have long called for the co-prescribing of naloxone and prescription opioids, but such measures have so far been rarely used.
How is Narcan administered?
The FDA determined as part of its decision this week that Narcan is simple enough to use with appropriate instructions on the packaging. Some experts do worry that an opportunity to educate users will be missed by excluding pharmacists, so here's some general advice:
- Signs of overdose include the person not responding, slowed or stopped breathing, blue or reddened limbs, and constricted pupils.
- To administer a dose of Narcan, tilt the person's head back and insert the atomizer plunger into one of their nostrils, then press to administer the dose.
- After administering the medication, call 9-1-1.
- If the person does not respond within a few minutes after the first dose is administered, a second dose may be needed.
However, while the FDA's decision should remove some barriers to access to naloxone, it has not completely eliminated them.
What's the price of narcan?
The main barrier to widespread distribution of naloxone remains its cost. Emergent BioSolutions did not immediately disclose what price it would set for the over-the-counter version of Narcan, but current data show the drug sells for between $20 and $100, which is a very wide price range.
Earlier studies show that even a one-time cost of $10 can be a barrier to purchasing a life-saving drug. This is especially true for people who use narcotic substances, as they are forced to buy illegal drugs.
At the Addiction Forum, participants suggested a maximum price of $20 per unit of the drug and a recommended retail price between $5 and $20 to make the drug more affordable and remove a financial hurdle for those who need it.
Health insurance typically covers the cost of Narcan in full or with a minimal prescription copayment, but over-the-counter forms of the drug are generally not covered. Public health advocates are urging insurance companies to continue to cover the over-the-counter version for free, but it is unclear whether they will do so. This creates a risk that people will choose not to purchase the drug for fear of reporting their or their family's drug use to their insurer. The availability of cheaper analogs of Narcan and other forms of naloxone could significantly lower the price barrier, and an FDA decision expected this week could pave the way for their approval.
Public health experts have called on the government to expand the availability of other forms of naloxone, such as liquid vials of the drug sold with syringes, which are often much cheaper — only about $4 — and often preferred by individuals already familiar with syringe use because of their addiction. Thus, there is still work to be done to maximize access to naloxone, as the need for it grows each year.
To answer the question about the effectiveness of Narcan against fentanyl: yes, it is effective. Let's go back a little bit: overdose death rates have risen dramatically over the past two decades. In 2000, about 20,000 Americans died from overdose — about one-fifth of the total number of lives lost by 2021. One reason for this was the widespread addiction caused by over-prescribing opioid drugs in the 1990s.
Another major factor is the increasing potency of the drugs people are using. In the mid-2000s, opioids such as OxyContin were the leading causes of death. People were either taking too many prescription pills because of chronic pain or injuries, or the drugs were ending up on the black market. By the 2010s, things began to change: due to the high price of prescription drugs and efforts to limit their distribution, heroin became a more affordable alternative. Drug cartels began actively importing heroin into the United States, as described in Sam Quinones' book Dreamland (2016).
According to a Kaiser Family Foundation study, the rise in fentanyl supply has coincided with an increase in overdose deaths, especially notable during the COVID-19 pandemic.
What has changed with the new U.S. policy?
The Trump administration has named overdose prevention as one of its top drug policy priorities, but a recently released preliminary budget draft suggests that about two dozen drug prevention and treatment programs will be cut.
But among the possible cuts listed in the budget proposal in April was a program that directly expands access to naloxone: a $56 million annual grant through the Substance Abuse and Mental Health Services Administration (SAMHSA) that helps distribute kits and trains rescuers and others on how to use them.
In FY 2023, the First Responders-Comprehensive Addiction and Recovery Act (FR-CARA) program distributed more than 101,000 opioid overdose rescue medication kits and trained nearly 77,000 people in their proper use, according to SAMHSA's budget request. Plans for FY 2025 increased that goal to 130,000 kits and expanded the number of trained professionals.
Officials from the White House Office of Management and Budget and the U.S. Department of Health and Human Services said final funding decisions have yet to be made, including possible cuts to naloxone distribution programs. As part of the HHS reorganization, SAMHSA will become part of the new Administration for a Healthier America, which the agency says is aimed at «better coordinating programs to care for the chronically ill, prevent disease, and pool health care resources for low-income Americans». However, supporters of the initiative fear that the loss of a key component of the strategy to combat the overdose epidemic in the U.S. could slow progress.
The Cherokee Nation Council received nearly a million dollars in FR-CARA grant funding for the tribe's harm reduction programs. The initiative is estimated to have distributed about 25,000 kits of Narcan, the trade name for naloxone, to law enforcement agencies, schools and communities in northeastern Oklahoma.
According to preliminary data from the U.S. Centers for Disease Control and Prevention, annual overdose deaths are down about 23% from their peak in mid-2023. Experts believe this trend is due to broad and systemic efforts, including increased access to naloxone. Despite the positive indicators, the number of overdose deaths remains above pre-pandemic levels, and experts emphasize that now is not the time to relax.
At a drug summit in Nashville last week, Kennedy characterized drug addiction as «a source of suffering, but also a symptom of deeper problems». He noted that young people need a sense of meaning in life to prevent addiction, and even suggested that banning cell phones in schools could reduce addiction.
He did not, however, comment on possible recent funding cuts to the Department of Health and Human Services, which many believe could jeopardize the effectiveness of prevention and overdose programs.