WASHINGTON -- The U.S. Food and Drug Administration announced Wednesday that it approved a nasal-spray version of naloxone, a drug that can reverse the effects of a heroin overdose. The new version will make it easier to administer and less intimidating than the previously approved injectable form. Commonly sold as Narcan, the drug has been widely viewed as an essential method of reducing overdose deaths that have spiked across the country in recent years.
“Combating the opioid abuse epidemic is a top priority for the FDA,” said Stephen Ostroff, M.D., acting FDA commissioner, in a press release. “We cannot stand by while Americans are dying. While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose.”
Advocates fighting the epidemic had already seen the value of a nasal-spray model and had been using them, even without FDA approval. For example, doctors operating a volunteer clinic in Kentucky had been handing out kits with a nasal applicator.
“It’s nice that [the FDA] are catching up with this,” said Dr. Mina Kalfas, a doctor who has worked with the naloxone clinic.
In June, a pharmacist in Boston offered a reporter working on a naloxone story a kit with the nasal spray. Tutorials for how to use the product can be found online.
In its press release, the FDA acknowledged the issue: “There has been widespread use of unapproved naloxone kits that combine an injectable formulation of naloxone with an atomizer that can deliver naloxone nasally. Now, people have access to an FDA-approved product for which the drug and its delivery device have met the FDA’s high standards for safety, efficacy and quality.”
Jason Merrick, board president of People Advocating Recovery, says the FDA-approved spray is an important step. The previous versions still had to be assembled, which might be difficult in an emergency.
“It’s all in one contained unit,” he said. “It’s more practical. I hope and pray it will be more affordable.”
Merrick said the cost of naloxone has skyrocketed along with demand. He had been paying $1 per kit just a couple of years ago. Now, those same kits are upward of $50, he said. Other versions are even more expensive.
Robert Childs, executive director for the North Carolina Harm Reduction Coalition, says price has been an issue. Since August 2013, Childs says his organization has passed out 18,680 two-dose naloxone kits and had more than 1,350 confirmed overdose reversals. The group could have passed out triple the number of kits, he says, if they were more affordable.
"The problem is the ability to buy it in bulk," he said. "Ideally, naloxone would be incredibly cheap."
But Childs says the the new nasal-naloxone model could be a "game changer for overall access." It's being offered to public interest groups at a cheaper price ($37.50) than what is currently on the market.
At a congressional hearing in April, Rep. Michael Burgess (R-Texas) wondered why the FDA hadn’t approved the medication for over-the-counter use.
“Right now, it’s hard to get,” Burgess said. “If it were available at a 24-hour pharmacy, not saying it could save every life at risk, it could save some. The downside of having it available is what?”
The hearing’s panelists of doctors and academics didn't reject Burgess’ idea. Dr. Marvin Seppala, the chief medical officer at the Hazelden Betty Ford Foundation, said he’d support the move. “We should have over-the-counter naloxone,” he said. “It’s a very innocuous drug.”
States such as Ohio and Kentucky have passed legislation that has cleared the way for pharmacies to sell the medication over the counter.
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