Some naloxone products could be safe enough for consumers to buy over the counter, according to a preliminary assessment the Food and Drug Administration announced Tuesday.
Naloxone is a drug used to mitigate opioid overdoses. The chemical reverses the overdose for 30 to 90 minutes to let a user breathe.
“Many states have laws that allow pharmacists to dispense naloxone without a prescription (called standing orders),” according to the Centers for Disease Control and Prevention, although a prescription is normally required.
“It is our preliminary opinion at this time that naloxone nasal spray up to 4 milligrams (mg), and naloxone autoinjector for intramuscular (IM) or subcutaneous (SC) use up to 2 mg, have the potential to be safe and effective for use as directed in nonprescription drug labeling,” the FDA wrote in its federal register notice published Wednesday.
The notice does not mean naloxone will be sold over the counter immediately. The FDA put out the notice to inform application holders for prescription naloxone products that the agency’s approval of over-the-counter naloxone may be forthcoming.
“Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone,” FDA Commissioner Robert M. Califf said in an announcement.
The FDA requires specific product submissions in order to make a final determination as to the efficacy and safety of over-the-counter naloxone.
“We need additional data such as product-specific data on the nonprescription user interface design, including packaging and labeling, to make a conclusive determination in this respect,” the FDA wrote in the register notice.
The FDA is taking written and electronic comments on the federal register notice until Jan. 17.