By: Shaina Matveev  | 

Access to Life-Saving Medication: A Closer Look at the FDA’s Recent Approval of Over-the-Counter Naloxone

Since the dawn of the 21st century, over one million individuals have died from drug overdoses in the United States, with a majority of these overdoses being caused by opioids. In 2021 alone, opioid overdoses resulted in over 80,000 deaths, a record-breaking high, and a number that continues to climb, with 136 people currently dying from opioid overdoses every day. Lowering these numbers will involve both preventing overdoses from occurring in the first place — a complex, systemic problem requiring much resources and research — as well as ensuring that overdoses are not fatal when they do occur, as with the use of the opioid overdose reversal medication called naloxone. 

This highly effective medication, commonly known by the trade name Narcan, saves over 93.5% of overdose victims treated with it by blocking the effects of opioids on the brain and restoring respiration, though barriers still exist in its accessibility. Historic strides were made this past month in expanding naloxone access when the US Food and Drug Administration (FDA) announced the approval of an over-the-counter (OTC) naloxone for the first time through a press release on March 29 — a decision that has the potential to save countless lives.

When first approved in 1971 by the FDA to treat overdoses through intravenous and intramuscular injections, naloxone showed great promise in the emergency medical setting. By 1996, 15 states and Washington, D.C., began developing programs to distribute take-home naloxone kits to laypersons, thus increasing naloxone distribution. However, this injection form of the medication was difficult to administer as a layperson, so in 2012 Phil Skolnick at the National Institute on Drug Abuse and Roger Crystal, CEO of Opiant Pharmaceuticals, began developing the easy-to-use Narcan Nasal Spray with a four-milligram formulation which was approved in 2015 by the FDA. A more potent two-milligram formulation was then approved in 2017. These nasal sprays were significantly easier to administer and dramatically increased the use of naloxone. However, while now easier to administer, barriers to obtaining naloxone were still in place.

Attempts to remove these barriers came in the form of state policies and laws, such as the widespread Naloxone Access Laws (NALs) placed in all 50 states starting in 2001, in addition to other efforts. These laws vary by state and expand who can distribute and receive naloxone, as well as simplify the process of obtaining it. They include standing orders and protocols to allow non-patient-specific distribution, grant pharmacists the right to prescribe naloxone and allow third-party prescribing to bypass the usual requirement of a provider-patient relationship, as well as provide protection against liabilities in prescribing, distributing and administering it. While these laws did expand naloxone distribution, many accessibility barriers still exist due to numerous complications, such as the failure of states to fully adopt these laws in practice and stigmas against drug users.

These stigmas are founded in long-standing societal prejudices and adversely affect patients, who may feel uncomfortable and worry about judgment in asking for naloxone, as well as distributors such as pharmacists, who may worry about offending patients by offering them this antidote. By approving an OTC naloxone nasal spray, these stigmas can be bypassed, and obtaining naloxone will become significantly easier. 

Additionally, an OTC naloxone will increase the number of not just pharmacies that carry it but other locations as well. While naloxone has also been distributed in the past in community-based naloxone programs, syringe service programs and other places, an OTC naloxone will have an even greater reach. Dr. Ruhal Gupta, director of the White House’s Office of National Drug Control Policy, explained to CNN that they will be encouraging “businesses, restaurants, banks, construction sites, schools [and] others” to purchase and distribute OTC naloxone. It will be available for purchase online, as well. 

According to the FDA’s March 29 press release announcing the approval of the OTC naloxone spray, “the timeline for availability” will be “determined by the manufacturer,” but it is estimated that these antidotes will hit the market by late summer. As of now, the FDA granted the OTC approval of Narcan to Emergent BioSolutions, however, this will affect other brand-name naloxone nasal spray products as well. Patrizia Cavazzoni M.D., director of the FDA’s Center for Drug Evaluation and Research, stated that they 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.” However, it is yet to be determined how much these treatments will cost when they hit the market.

Keeping prices low is of utmost importance in ensuring that a maximal number of individuals can obtain OTC naloxone, regardless of their income level. Inconsistent with this goal of affordability through accessibility, Emergent BioSolutions’s Narcan Nasal Spray currently holds a monopoly and might charge prices far out of the price range of those most in need of this product. Joshua Cohen, in a Forbes article, suggests that they could charge as much as $70 and explains that competitors are needed. One emerging competitor is the nonprofit Harm Reduction Therapeutics, whose inexpensive formulation called RiVive is currently being fast-tracked for approval by the FDA. Hopefully, this will be one among many emerging competitors helping create a healthy market best suited to provide the public with affordable products.

With every day that passes, more and more lives are being lost to the opioid epidemic, blanketing this growing public health crisis with feelings of hopelessness and despair. But with every step taken towards saving lives from its clutches — from the formulation of the naloxone drug, to its development in the nasal spray form, to the widespread Naloxone Access Laws, not to mention the extensive efforts of countless individuals researching this epidemic, working on lowering stigmas and fighting to increase accessibility to all forms of treatment — hope is found. This latest historic improvement in increasing naloxone access, the approval of the OTC Narcan Nasal Spray, is yet another step, another victory, and another ray of hope in this fight, building the glimmer of light at the end of this dark tunnel and representing the countless lives that will be spared along the way.

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Photo Caption: The FDA recently approved an over-the-counter naloxone.

Photo Credit: Unsplash