Study to help FDA determine feasibility of making naloxone—a drug to treat opioid overdoses—available over-the-counter

Research Triangle Park, NC – In an effort to combat the opioid epidemic in the United States, RTI International will work with Concentrics Research to determine the feasibility of making naloxone available over-the-counter by conducting label comprehension studies for the U.S. Food and Drug Administration.

Naloxone, a drug used to treat opioid overdoses, is currently available only by prescription.

“Despite reports to the contrary, certain states and pharmacy chains have not made naloxone over-the-counter or ‘without a prescription,’” said Claudia Squire, public health analyst at RTI and project director for the study. “What states have done is expand prescribing authority to include pharmacists, cooperative agreements with physicians, and other approaches—like standing order prescriptions—to increase access. Our study is one step toward determining actual over-the-counter feasibility that could make naloxone available from pharmacies to gas stations in all 50 states.” 

Naloxone is nearly 100 percent effective in reversing the effects of an opioid overdose and rarely causes serious adverse events. Further, if it is mistakenly administered to someone not on an opioid, it has no pharmacological activity, and is safe.

Opioid-related overdose deaths in the United States have increased from 7.9 per 100,000 people in 2013 to 9.0 per 100,000 in 2014. The Centers for Disease Control and Prevention estimates that between 14,000 and 19,000 people died from opioid overdoses in 2014, which is twice as many as estimates from 1999.

“We need to combat the opioid epidemic from many fronts,” said Mark Edlund, M.D., Ph.D., RTI senior research scientist and expert consultant on this project. “Naloxone saves lives, yet research is necessary to assess the feasibility of making it more accessible, including the possibility of over-the-counter naloxone.” 

In order for a drug to be administered without medical supervision, the FDA requires that label comprehension studies be conducted to demonstrate that laypeople can use it safely. To assess label comprehension, the study will include cognitive testing to ensure participants understand the label, the scenarios in which naloxone should be used, and how to safely administer it.

“For this study, it is particularly important that it is designed and conducted in such a way that is both relevant and sensitive to such a highly vulnerable target population, an area of expertise for RTI,” Squire said.

Among the target population for the study are adult and adolescent prescription opioid and heroin users and their friends and families. The research team will recruit 710 participants from several locations across the country.

“We are pleased to be working with RTI,” said Julie Aker, president and CEO of Concentrics. “We have over 30 years of experience and have conducted nearly 300 label comprehension studies that have been submitted to FDA.”

leader in opioid research, RTI leads a variety of multidisciplinary studies to better understand, prevent, and treat opioid misuse and abuse.

Naloxone

Highlights

  • RTI International will work with Concentrics Research to determine the feasibility of making naloxone available over-the-counter
  • Naloxone, a drug used to treat opioid overdoses, is currently available only by prescription