Yesterday, the US Food and Drug Administration (FDA) approved the first ever over-the-counter form of naloxone. This approval applies only to the 4mg nasal spray manufactured by Emergent Biosolutions, which is significantly more expensive than other more affordable versions. including intramuscular naloxone. In response, New Jersey Harm Reduction Coalition (NJHRC) released the following statement.
Jenna Mellor, Executive Director, NJHRC:
“The FDA’s decision is an important milestone toward getting naloxone out from behind pharmacy doors and into the hands of people who need it. Naloxone is a safe, lifesaving medicine that is essential for people who use drugs to survive the overdose crisis, and it should be as easy to find as Advil or Tylenol.
“Now, federal policymakers must build on this win to ensure that naloxone is not only available but affordable. The FDA’s decision only applies to one version of naloxone, produced by one manufacturer, which excludes more affordable versions of naloxone and risks driving up the over-the-counter price.
“Naloxone is only as effective as it is widely available, and its high cost remains the single biggest barrier to its availability. Whether it’s a state like New Jersey, a local health department, or a community group, buying naloxone at the scale needed to stem the overdose crisis will only be possible if the FDA also approves more affordable versions of naloxone over-the-counter. More affordable versions of naloxone, including generic intramuscular naloxone, are already approved by the FDA for community distribution and have been used to reverse thousands of overdoses in states like New Jersey, California, and Texas. We have every reason to make all forms of naloxone available over-the-counter. It’s good for public health, it’s good for public finances, and it will make every dollar invested in naloxone distribution go farther to save lives.”
