Creating Competition for Naloxone

In a companion to the SUPPORT Act reauthorization, lawmakers proposed that the U.S. Department of Health and Human Services update regulations and grant guidance to include all overdose reversal agents approved by the U.S. Food and Drug Administration (FDA). Proponents of the legislation claim the government “has inadvertently created a monopoly” for naloxone and that this change will rectify that by encouraging increased competition.

However, it is not clear that giving legislative and regulatory preference to naloxone has hindered the nation’s fight against the overdose crisis. The medication has a long-established efficacy and safety profile, and its increased community distribution in recent years has contributed to the dramatic decline in overdoses from their peak of more than 114,000 to roughly 80,000 in January 2025.

Nonetheless, the innovation and cost-cutting benefits of increased competition could potentially improve the nation’s overdose response going forward if efforts prioritize the needs of consumers—people who use drugs—and address challenges with current products.

Why Overdose Reversal Medications Matter
The United States has been grappling with an overdose crisis for more than a decade. Drug-involved deaths have been climbing in the United States since the since the 1970s. Over the past decade, the influx and gradual proliferation of fentanyl—a synthetic opioid about 50 times stronger than heroin—drove an unprecedented surge.

Naloxone is a safe and easy-to-use medication that, when administered promptly, restores breathing within minutes. Governments have begun to turn the tide on the overdose crisis by reducing barriers to naloxone for potential overdose responders, particularly people who use drugs, their friends, and their loved ones.

A number of policies have facilitated getting naloxone into the hands of laypeople:

• State naloxone access laws permit pharmacists to prescribe the medication or dispense it without a prescription.
• The FDA approved intranasal, standard-dose formulations for over-the-counter retail sale.
• Good Samaritan legislation provides liability and criminal protections to people who respond to an overdose, call 911, and administer the medication, encouraging them to act as rescuers.

Tipping the Scales for Intranasal Naloxone
There is no question that improved naloxone access saves lives. At the same time, the laws that facilitated it created a system that favors just one type of product: intranasal naloxone. For example, legislative language often refers to improving access to naloxone rather than using broader terminology like “opioid antagonist” or “overdose reversal medication.” In addition, the prescription status of injectable naloxone and health department preference for intranasal formulations have slanted the market toward intranasal delivery.

Limitations of Current Naloxone Supply
While naloxone is a safe and effective medication, it may not be perfect for every scenario—especially when only available in limited formulations.

First, fentanyl’s dominance of the drug supply has driven many people who use opioids to switch from injecting to smoking opioids. In addition, public overdoses have become more common, such that responders are more likely to not use drugs. Consequently, more overdose responders may be unfamiliar or uncomfortable with needles and prefer to administer the medication intranasally. However, intranasal naloxone remains too expensive for many individuals or organizations to purchase. While the emergence of nonprofit, generic, and state-supported products has helped drive prices down somewhat, fixed supply chain costs contribute to high pricing baselines.

In addition, the popular naloxone products may be less than ideal in some circumstances. Intranasal naloxone is slower acting than intramuscular and thus may require more doses. Nonetheless, because many health departments purchase the intranasal product, this may be the only version available to some people. All forms of naloxone effectively reverse overdoses involving potent opioids like fentanyl; however, they are less effective when administered after the overdose has progressed to cardiac arrest.

Finally, all available overdose reversal medications—including naloxone (especially high-dose) and nalmefene—can cause severe withdrawals in people who are opioid dependent. Imposing these symptoms on a person has been described as inhumane. What’s more, the experience of precipitated withdrawal can undermine trust in the healthcare system and lead an individual to seek opioids to alleviate the discomfort. Buying and consuming opioids while in active withdrawal is, in turn, associated with an increased risk of overdosing again.

How to Ensure Competition Helps Rather than Harms
Increased competition among overdose reversal products could help overcome some of these challenges. However, to truly address the limitations of current naloxone products, research and development must be undertaken deliberately, prioritizing the needs of end users (individuals who use drugs and are at risk of overdosing or likely to respond to an overdose). Overdose reversal research should:

Aim to Reduce Cost
More versions of existing products—especially as a nonprofit producer entered the scene and generics became available—have begun pushing more affordable prices of standard-dose intranasal naloxone. Even so, prices remain too high for many people who use drugs and even some of the organizations that serve them.

One factor driving the persistently high price of intranasal naloxone is the supply chain. Although there are a number of intranasal medical devices on the market, just one is considered top-of-the-line when it comes to dose precision, making the device globally preferred by intranasal naloxone manufacturers. However, the patent expired in 2020, leaving space for price pressure from generic alternatives if they can match the brand-name device’s efficacy. In addition, development of novel nasal spray or other layperson-friendly devices could create competition within the supply chain that would help drive costs—and, in turn, prices—down.

Provide Options for Delayed Response
One of the biggest challenges in overdose reversal is the absence (if a person is using alone) or delay (for example, if bystanders are intoxicated or not sufficiently able to identify an overdose) of human response. Delays increase the risk of brain injury and the likelihood that the overdose will progress to cardiac arrest.

The two currently FDA-approved overdose reversal medications are helpful for this problem. Naloxone does reverse cardiac arrest in many cases, but not as consistently as it reverses respiratory depression, making it a less effective medication in delayed overdose responses. Approved for overdose reversal in 2023, opioid antagonist nalmefene is better at reversing cardiac arrest but causes severe and long-lasting withdrawals that can undermine trust in the medical system and drive a person to overdose again in an attempt to relieve the symptoms.

Pharmacological research could identify novel compounds that work better than naloxone for reversing cardiac arrest without causing the suffering and risk associated with nalmefene.

Minimize the Risk and/or Severity of Precipitated Withdrawal
In opioid-dependent individuals, all currently available overdose reversal medications can cause precipitated withdrawals. Opioid withdrawal causes sleep disturbances, gastrointestinal distress, flu-like symptoms, and more. These symptoms are extremely uncomfortable—in some cases life-threatening—and can drive individuals to engage in a range of high-risk behaviors in an effort to find relief.

Among these risky behaviors are “subsequent increased use and opioid seeking,” which can lead an individual to relapse into overdose.

Conclusion
Federal legislators’ recent move to encourage competition in the overdose reversal market has the potential to provide harm reductionists and people who use drugs with more effective tools to combat the overdose crisis. However, identifying and developing alternatives to current medications will only be relevant if these efforts aim to solve problems identified by people at risk of overdose and those who serve them. This means finding ways to reduce the cost of intranasal naloxone, improving efficacy when response is delayed, and minimizing the likelihood or severity of withdrawals.