FDA approves over-the-counter Narcan nasal spray for opioid overdoses
Key takeaways:
- The transition from prescription to over-the-counter status will be determined by the manufacturer but could take months.
- The retail price of Narcan may be unaffordable for many patients.
The FDA on Wednesday approved 4 mg Narcan nasal spray for over-the-counter use as an emergency treatment for opioid overdose. It is the first naloxone product to be available without a prescription.
“We’re very excited that naloxone will be made available over the counter,” Chuck Ingoglia, president and CEO of the National Council for Mental Wellbeing, told Healio. “We need to empower communities, families and individuals to combat the opioid epidemic. I think this is a great tool to do that.”
The OTC availability of 4 mg Narcan nasal spray (naloxone hydrochloride; Emergent BioSolutions) comes amid an increasing trend in fatal opioid overdoses. There were 16,706 overdose deaths involving prescription opioids in 2021, up from 14,139 in 2019, per National Institute on Drug Abuse data.
The timeline and availability of the nasal spray will be determined by the manufacturer, according to an FDA press release. Other formulations and dosages of naloxone will remain available through prescription only.
The FDA said it will continue working with stakeholders to ensure the availability of naloxone nasal spray throughout the time needed to transition the product’s status from prescription to OTC, which could take months.
“Further, we will work with any sponsor seeking to market a nonprescription naloxone product, including through [a prescription] to OTC switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the release.
The FDA noted that the approval of OTC Narcan will require a change in the labeling of 4 mg generic naloxone nasal spray products that list Narcan as their drug product. The approval could also affect other brand-name naloxone nasal spray products of 4 mg or less, although such determinations would be on a case-by-case basis, the agency said.
The approval is the culmination of multiple assessments taken by the FDA in recent months to ensure greater access to naloxone products. In November, the agency encouraged application holders of prescription naloxone products to apply for OTC switches after early findings suggested the products could be safely used without a prescription.
Despite the achieved OTC status, concerns remain on how accessible the nasal spray will be for consumers. According to Ingoglia, the retail price of the product is around $70.
“The current retail price will leave it out of reach for many people. We’re very hopeful that the maker will revisit that,” Ingoglia said. “We’re going to need to make sure that more people understand that this is available, so we need public education, and also make sure that physicians and pharmacists feel comfortable recommending people to have Narcan available.”
References:
- Drug overdose death rates. https://nida.nih.gov/research-topics/trends-statistics/overdose-death-rates. Accessed March 29, 2023.
- FDA approves first over-the-counter naloxone nasal spray. https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray. Published March 29, 2023. Accessed March 29, 2023.
- The Biden-Harris Administration takes critical action to make naloxone more accessible and prevent fatal overdoses from opioids like fentanyl. https://www.hhs.gov/about/news/2023/03/29/biden-harris-administration-takes-critical-action-make-naloxone-more-accessible-prevent-fatal-overdoses-opioids-fentanyl.html. Published March 29, 2023. Accessed Mar 30, 2023.
Perspective
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The approval of naloxone for nonprescription sale is good news. It puts the antidote into the hands of people who need it at a time that it’s needed. Recognizing the classical signs of a depressed level of consciousness — pinpoint pupils, and most importantly, slow to no respiratory effort — in the absence of other explanations should prompt administration of naloxone, an opioid receptor antagonist. Despite the recognition of the tragic consequence of opioid overdose and the important focus on public health, there are still some questions that remain about this move. Efficacy is unquestionable, some real-world use safety concerns remain, but most questions are logistical, like cost and accessibility.
What will the price be? Presumably, it will cost less than it is when obtained by prescription, but is it going to be low enough that anybody can afford to have extra doses around just in case they need them? Without a prescription, will it still be covered by insurance, or will there be a workaround to getting it paid for? Will it be freely accessible to the customer on a shelf, or will it be behind the counter or in a locked case? The need to interact with a pharmacist or clerk presents a barrier rooted in stigma and laden with inconvenience.
There may be unintended consequences. Although naloxone administered to patients without opioid dependence is harmless, precipitating opioid withdrawal in those who are dependent can have consequences. For example, the craving and anxiety can lead people to use more opioid to overcome these feelings, a practice with dangerous consequences of recurrent overdose, highlighting the importance of seeking immediate medical care.
Precipitation of withdrawal can be mitigated by using only a single dose of naloxone, and rarely someone may require two. However, the misperception that successful reversal requires patients to immediately regain full consciousness often leads to administering multiple doses. Opioids, including fentanyl, readily respond to naloxone, but the effect can take minutes, which may feel like hours under the extant circumstances. Critically, the clinical endpoint is not arousal but rather regaining sufficient respiratory effort to provide oxygen to the brain. Many patients do not wake up, but if they are breathing six or eight times per minute, there is time to await EMS. Often gentle physical stimulation may prompt them to breath; if no naloxone is available, rescue breathing, as appropriate, can be performed.
Overzealous administration of naloxone in these situations risks other serious harms like pulmonary edema or myocardial infarction due to the stress of severe withdrawal. The vomiting associated with withdrawal may lead to pulmonary aspiration in unconscious patients who do not regain the ability to protect their airway.
The available device delivery systems are easy to administer and safe when used properly. Many overdoses will be reversed, and a number of lives will undoubtedly be saved. We just have to assure that this new antidote is affordable, accessible and utilized.
Professor and chair, department of emergency medicine
Chief, division of medical toxicology at Rutgers New Jersey Medical School
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