This week’s FDA approval of the first-ever over-the-counter (OTC) naloxone product (Narcan) for the treatment of opioid overdoses was broadly praised, but medical and industry experts expressed caution about expanding access and its potential to address the overdose crisis.
“We have nearly 200 Americans dying every day as a result of opioid-involved overdose,” said Smita Das, MD, PhD, MPH, of Stanford University School of Medicine and chair of the Council on Addiction Psychiatry for the American Psychiatric Association (APA). “Anything that we can do to make overdose reversal possible is a step in the right direction.”
Most statements from medical societies and other organizations, including the American Medical Association (AMA) and the Consumer Healthcare Products Association (CHPA), noted that the approval is a critical step in addressing the deaths from opioid overdose.
“While government decisions are often incremental, FDA’s decision will transform how we compassionately and logically respond to the overdose epidemic,” said Bobby Mukkamala, MD, chair of the AMA Substance Use and Pain Care Task Force, in the AMA statement.
Mukkamala, who wrote a recent opinion piece for MedPage Today on the topic, said that the decision will finally ensure that individuals most at risk of overdosing will have improved access to this product, and emphasized that manufacturers need to keep the price of naloxone affordable to allow for more equitable outcomes.
Barbara A. Kochanowski, PhD, the senior vice president of regulatory & scientific affairs at CHPA, told MedPage Today that the FDA’s decision was the right one.
“It was important for FDA to show leadership overall in the opioid crisis,” she said. “It’s a piece. It isn’t the one solution, but it’s certainly one step, which is terrific.”
Limitations of OTC Access
Despite the many benefits of OTC naloxone, some experts are concerned about its ability to meet the high expectations people have for it.
“I appreciate the attention that’s been brought to the issue,” Das said. “I also hope that collectively we recognize that overdose is a symptom of a larger issue.”
She noted that more attention should be given to the fact that overdoses are not always simply a case of a person needing an opioid reversal treatment.
“We need to work collaboratively as psychiatrists, physicians, governments, [and] communities to address the substance use disorders that our nation is facing,” she said.
Another major concern is the potential for OTC naloxone to fall victim to a pharmaceutical profit race. A STAT article on pricing published this week outlined the changes that are being made by companies in an effort to increase prices and profits from naloxone. Many companies have introduced products that look and work very differently from the OTC 4-mg naloxone hydrochloride nasal spray that was approved by the FDA.
The STAT article suggested the possibility that “pharmaceutical companies have used the opioid crisis, and the nation’s fear of fentanyl, to aggressively market high-cost naloxone products that divert resources away from cheaper forms of the lifesaving medication.”
Still, there are reasons to believe that the FDA might continue to push for more access to affordable products. David Spangler, JD, senior vice president of legal, government affairs, and policy at CHPA, told MedPage Today that the FDA took an unusual step in its announcement of this decision, by specifically highlighting the need to alert other companies with naloxone products about this change in labeling.
This nuanced step, he said, will help companies quickly move toward developing abbreviated new drug applications to apply for OTC indications of their own naloxone products.
“I was very pleased and reassured to see FDA acknowledging that it needs to inform those abbreviated new drug application sponsors,” he added.
Need for an Equitable Rollout
The enthusiasm for the approval of OTC naloxone was also accompanied by calls from experts to carefully roll out the delivery of this product to consumers.
Bonnie Milas, MD, of the University of Pennsylvania in Philadelphia and a member of the American Society of Anesthesiologists (ASA)’s committee on trauma and emergency preparedness, emphasized the need for naloxone to become widely available, especially in places where overdoses are most likely to occur.
“I see this as part of every home’s first-aid kit. That’s where it needs to be first and foremost, is in the home,” Milas told MedPage Today. “[It’s] very critically important because of the fact that most people who overdose, they overdose either in their home or in someone else’s home.”
That is why Milas, who lost two sons to overdose, has advocated for the FDA to expand free access programs, even after OTC naloxone has become available. In addition to expanding free access to naloxone, Milas and the ASA have been active in promoting increased education around naloxone through the REVIVEme initiative, which includes resources that healthcare providers and consumers can use to better understand the risks and benefits of naloxone.
“First and foremost, we have to put the medication and the skills in the hands of citizens,” Milas said. “That’s what is going to be critical in reducing injury … And that is the critical piece that’s been missing. We have not had a nationwide push for this type of agenda in the United States.”
Kyle A. Weant, PharmD, of the University of South Carolina College of Pharmacy in Columbia, told MedPage Today that healthcare providers will have a critical role to play in educating the public about the availability and need for naloxone.
“This actually has downstream potential for reducing healthcare costs and also limiting the utilization of limited resources,” he said.
Weant also noted that early naloxone use could have benefits for emergency services and hospitals, pointing out that many people who overdose are young and have the opportunity to live much longer, healthier lives if they receive naloxone early. The longer it takes to administer the medication, the worse the long-term outcomes will be, he added.
“It’s not always just people with opioid use disorders that are overdosing and needing naloxone,” he said. “There are children that are getting into their grandparents’ opioids and overdosing. There are oncology patients that are on opioids because of their chronic pain that are unintentionally overdosing. There are elderly patients that forget that they took their medicine. They take it twice and now they’ve overdosed, so this is something that should be dispensed with all opioids for everybody.”
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