When the life-saving properties of naloxone entered the world more than four decades ago, nobody realized how valuable it would become. The drug itself costs pennies, and is used regularly in hospitals to reverse sedation and anesthesia, as well as in emergency settings to rescue people from opioid overdoses. Then the opioid epidemic took over the nation and, starting a few years ago, naloxone became increasingly important for harm reduction activists and first responders to have on hand. It also became obvious that it would be a good medication for families of opioid users to have in case of an accidental overdose, even of a prescription pain medication, and for families of patients newly enrolled in opioid treatment programs.
But this brought the medication into a new arena. The only naloxone currently approved by the Food and Drug Administration (FDA) is available in vials (which require a needle and syringe) or pre-filled syringes—both requiring medical expertise to inject—or, more recently, in a very expensive auto-injector that does not require medical expertise.
And with the new arena came new marketing opportunities, apparently, because the price of naloxone doubled about a year ago. This has created some bitterness from buyers who see a pharmaceutical company gouging at a time of need. Currently there is only one supplier, although two other naloxone products are undergoing FDA review.
Before the availability of the auto-injector, approved in April 2014, many people (including addiction treatment professionals) had figured out how to use the vial without a needle. By connecting it to an intranasal atomizer, they could administer the naloxone into the nose, and rescue the victim that way. However, the FDA has not approved this as a delivery method, so neither the FDA nor Amphastar Pharmaceuticals, which makes the naloxone vials and prefilled syringes, can talk about it.
More than two years ago, pharmaceutical company Endo, which made naloxone trade-name product Narcan, stopped selling it. There have been shortages, but ever since naloxone's price doubled last year, there seems to be plenty to go around. A year ago it cost about $50 to get a naloxone kit, consisting of an atomizer and the medication. Now it costs about $100. The Evzio auto-injector costs more than $500.
Addiction Professional spoke for this article with a treatment program that started the first large naloxone buying and training programs using the atomizer; the founder of Kaleo, which makes the Evzio auto-injector; and a purchasing cooperative that buys naloxone for mayors, governors and counties, about the hard realities of this drug.
Naloxone as a commonly used overdose rescue drug came into its own more than three years ago when Gil Kerlikowske, then director of the Office of National Drug Control Policy (ONDCP), traveled to North Carolina to promote use of the medication along with Fred Wells Brason II, executive director of Project Lazarus, a not-for-profit organization focusing on rescuing overdose victims. At the time, naloxone manufacturers were being pressured by the federal government to increase production of the drug. Project Lazarus provides kits that include two doses, atomizers, and instructions.
Project Lazarus doesn’t directly provide the naloxone; it provides the prescription for two doses, which the pharmacy has to fill. The kit costs $12. The cost of the naloxone is $39 per dose, says Brason. It’s always important to have two doses, because one may not be enough to rescue the victim. In some states, Medicaid will cover the atomizer. Sometimes insurance covers the naloxone. Project Lazarus also has had grants available in the past.
“We sell a few thousand kits a year, to law enforcement, to anybody who wants them,” says Brason. “Until there are sufficient products out in the marketplace, we’ll do what we need to do in order to save a life.”
There was an “outcry” when Amphastar doubled the price of naloxone a year ago, said Brason. Likewise, there is consternation about the high cost of the Evzio auto-injector. But Brason blames the healthcare system, adding that very few people actually pay the listed price.
“When a new product comes out and they determine what their pricing needs to be, they need to bring it up to a certain ceiling, because then they negotiate rates with Medicaid, and private payers,” he says.
The two products currently under FDA review are both intranasal—one is a single device that doesn’t require an atomizer. Nobody knows for sure what the pricing will be, says Brason, but most expect that competition will keep prices down.
When the FDA approved the auto-injector as a take-home device, it did so without any requirement that there be a diagnosis accompanying the prescription, says Brason. “That was a great thing.”
He believes in co-prescribing, so that any patient who gets a prescription from a physician for an opioid would also get a prescription for naloxone. “Having naloxone readily available is necessary to prevent death, in case a patient makes a mistake” with an opioid prescription, he says. It’s also preventing death in someone who was formerly addicted and hasn’t used opioids recently, but goes back to the drug and takes too much by mistake, not realizing how the tolerance level has changed.
“I want it to be mainstream,” Brason says of naloxone.
Eric Edwards, MD, PhD, medical director of auto-injector manufacturer Kaleo, couldn’t agree more. That’s why the Evzio device automatically injects the drug, with no needle ever exposed or seen. The device even gives instructions. He compares the technology to that of defibrillators, which can save people who are having heart attacks.