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FDA is working on innovative ways to facilitate the process of helping manufacturers pursue approval of an OTC naloxone product to increase the access and use of this life-saving drug.
Naloxone is a medication called an “opioid antagonist” used to counter the effects of opioid overdose. Specifically naloxone is used in opioid overdoses to counteract the life threatening depression of the central nervous system and respiratory system, allowing an overdose victim to breathe normally.
From the world wide analysis in 2014, it was noticed that 28,000 people died due to overdose death involving the prescription of opioids such as oxycodone, hydrocodone, morphine and illicit opioids such as heroin and illegally produced fentanyl raised to tripled since 1999. Many of these tragedies could have been avoided if the people who had experienced the overdose has been immediately given the prescription of drug naloxone which has been proven to be a life-saving medication that can stop or reverse the effects of an opioid overdose.
Naloxone is still prescribed in all 50 states and the District of Columbia, though many have or are taking steps to make naloxone more accessible. Consistent with our opioid action plan announced earlier this year, the FDA is still exploring the options to make naloxone more available to treat opioid overdose. This could be an option that to identify the ways which can assist the manufactures in submitting an application to the FDA for an over the counter (OTC) version of a naloxone product.
It has been observed that FDA is working on innovative ways to facilitate the process of helping manufacturers pursue approval of an OTC naloxone product, also develop the package label that would be required for such a product. This is an important step to increase the access and use of this life saving drug.
Although the two currently available prescription of naloxone products intended for the use in community- an auto-injector product for self-injection and a nasal spray formulation that have instructions for use as they do not have the consumer-friendly Drug Facts Label (DFL) which is required for OTC drug products. However, before submitting a new drug application or supplement for an OTC drug product, companies should develop this DFL and conduct the required studies to show that consumers can follow the DFL to understand how to use the product without the help of a healthcare professional.
To facilitate the development of OTC naloxone, the FDA has created a model DFL and an accompanying simple pictogram that could be placed next to the DFL to visually correspond to the label directions. This model DFL and pictogram are intended to provide consumers with the information they would need to understand that how can they safely use naloxone and when it is appropriate to purchase naloxone. It should also be described that how to use it in an emergency opioid overdose situation. Since it is a model label, information that is highly specific to a particular product would not be included.
FDA has also arranged label for comprehension testing of the model DFL. This testing is now being conducted and we expect that the results will yield important information about consumer understanding of the model naloxone DFL. Using this information, naloxone manufacturers might be then able to focus their final label comprehension testing on how well consumers understand product specific information such as instructions for the device that delivers naloxone that has not been already tested on the model DFL.
Creating a model DFL and arranging for label comprehension testing are among the ways that the FDA is working to fulfill our commitment to enhance the access of naloxone access where opioids action plan. We will continue to work with the interested manufacturers and developers to further explore the best uses of naloxone for the emergency treatment of known or suspected opioid overdoses until emergency medical help arrives.
It has been declared that FDA's opioid action plan is part of the comprehensive Opioid launched by the U.S Department of Health and Human Services (HHS) in March 2015. The Initiative focuses on the high-impact strategies for:
1. Improving the opioid prescribing
2. Expand access to medication-assisted treatment for opioid use disorders
3. Increasing the use of naloxone to reverse opioid overdoses.
FDA
Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths
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