By Leah S. Poniatowski, J.D.
FDA satisfied with independent study results, releases models of drug facts labels for stakeholders pursuing non-prescription approval of opioid antagonist.
In an effort to help stem the opioid crisis, the FDA has made model drug facts labels available for naloxone, an opioid antagonist, allowing sponsors to seek non-prescription approval and make the drug more widely available (Notice, 84 FR 8728, March 11, 2019).
Background. Following an opioid overdose, the respiratory and central nervous systems become depressed to life-threatening levels. Naloxone is a prescription opioid antagonist and, if timely administered, can save the life of someone experiencing an overdose. In light of the public health crisis presented by the increased misuse and abuse of illicit and prescription opioids, the FDA recognizes that making naloxone more broadly available can help stem the deaths from overdoses. At present, naloxone is only available by prescription and must be approved for non-prescription use.
Behavioral studies. In order for a prescription drug to be approved for non-prescription use, the drug sponsor must conduct consumer behavior studies to ensure the safety and efficacy of the drug without professional supervision. With respect to naloxone, some sponsors have indicated that the study requirement presents a burden to develop the nonprescription version of the drug. In response, an independent research contractor undertook a 700-person study of label comprehension using two FDA-created model drug facts labels, reflecting the two methods of administration: nasal spray and injector. An FDA team separate from the label development group concluded that the label comprehension study results were adequate and that the labels can be used. Sponsors interested in marketing non-prescription naloxone can base their label on the models and add device-specific information. Sponsors would need to retest label comprehension thereafter.
FDA interaction. Sponsors interested in developing nonprescription naloxone are strongly encouraged by the FDA to contact the Division of Nonprescription Drugs Products to request a meeting concerning their drug development programs.
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