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SILVER SPRING, Md., Jan. 17, 2019 / PRNewswire / – The number of overdose deaths from prescription and illicit opioids has more than doubled in the last seven years, reaching almost 48,000 in 2017, it is essential that we continue to tackle this tragedy. from all fronts. This includes new ways to increase the availability of naloxone, a drug used to treat overdose of opioids.
In case of opioid overdose, the person may lose consciousness and his breathing may become superficial or stop. This can quickly result in death if there is no medical intervention.
However, if naloxone is administered quickly, it can counter the effects of overdose, usually within minutes. Although the person administering naloxone should also consult the patient immediately, the end result is that increased availability of naloxone and rapid action to administer it can save lives.
Naloxone is an essential drug to help reduce the number of overdose deaths from opioids. The prevention and treatment of opioid overdose is an urgent priority. The increased availability of naloxone for the emergency treatment of overdoses is an important step. One potential way to improve access to naloxone is to make it available for cash sales. The FDA-approved versions of naloxone currently require a prescription, which can be a barrier for people who are not treated by a doctor or who may be ashamed or even afraid to admit their addiction problems. The large-scale availability of naloxone, for example as an approved TBT product, is an important step forward for public health and a need we are already working on at the FDA.
Although FDA-approved prescription naloxone formulations include instructions for use for product labeling, they do not carry the consumer-friendly drug sheet label ( DFL), which is mandatory for over-the-counter medications. Before submitting a new drug application or a supplement for an over-the-counter drug product, companies must develop a DFL and conduct studies showing that consumers can understand how to use the product without the supervision of a health professional. health. Some stakeholders have identified the need for these studies as a barrier to the development of over-the-counter naloxone products.
To encourage pharmaceutical companies to enter the OTC market and increase access to naloxone, the FDA has taken an unprecedented step: we have developed a DFL model with easy to understand pictograms on how to use the drug. We also performed label comprehension tests to ensure that the instructions were simple to follow.
This is the first time that the FDA has been developing and proactively testing an LDF for a drug intended to support the development of an over-the-counter product. We have proactively designed, tested and validated the essential labeling requirements to approve an over-the-counter version of naloxone and make it available to patients. One of the key components of OTC availability is now in place. In short, we have developed a labeling model that sponsors can use to gain approval and increase access to naloxone over-the-counter. This action was part of our broader commitment to deal with the opioid crisis.
Today, we announce the results of our work, including the release of two models of LDF (one to use with a nasal spray and one to use with an auto-injector) and the review at l-39. support from the FDA. These efforts should boost the development of over-the-counter naloxone products to promote wider access to this drug. The LDF template contains the information (with the exception of specific product-specific information) that a consumer needs to administer naloxone safely and effectively.
During this period with no budgetary allocation for the FDA's fiscal year 19, we strived to pursue the critical aspects of our work, within the limits permitted by law. At present, for products (such as naloxone) covered by a fee-for-use program, our review of existing medical product applications and the development of related policies with respect to our review are funded by limited deferred usage fee balances. We will continue to inform the public of how we approach our work when the credits are up.
The LDF consumer's understanding of the model was iteratively tested by an independent research contractor as part of a pre-specified research design involving more than 700 participants from a wide range of potential naloxone users. free sale. This included people who ate heroin; people who use prescription opioids; the family and friends of people who use opioids; teens; and the general public. An FDA review team that was not directly involved in the study reviewed the study report independently and determined that the results of the understanding were satisfactory. Overall, the study showed that consumers were familiar with the LDF model and that it was acceptable for manufacturers to use it as part of their over-the-counter naloxone development programs. Using this information, naloxone manufacturers can now focus their efforts on the final label understanding test to determine how well consumers understand product-specific information that is not yet available. been tested in the DFL model. I personally urge companies to take notice of this path opened by the FDA and to submit claims to the agency as soon as possible.
The DFL model is available in two versions. One is for use with a nasal spray and the other with an auto-injector. However, product-specific instructions in each release are placeholders that have not been tested by the FDA for understanding or performance of human factors. Sponsors may replace these placeholders with their own product-specific information and test them if necessary. In addition to this product-specific information, the DFL also contains all the key information that an uninformed third party needs to know to administer naloxone. In designing the model LDF model, the FDA team solicited feedback from multiple addiction stakeholders, as well as internal FDA experts, to streamline the DFL so that it does not contain as the most critical information, in order to facilitate their understanding. emergency. We are grateful to the hundreds of study participants who helped us to see this LDF through their eyes, which allowed us to refine the LDF several times until we got it. reached a final version. These research participants have made these efforts possible.
This work builds on our ongoing efforts to ensure that this life-saving medicine is in the hands of those who need it most. In addition to the approval of the use of injectable naloxone in a health care facility, as well as prescription auto-injectors and intranasal forms of naloxone, which facilitate the use by non-users of initiated, we have also published a draft directive to advance the development of the generic spray for naloxone hydrochloride.
In addition, last month we held a two-day Advisory Committee meeting to seek advice and guidance on strategies to increase the availability of naloxone products for use in the community. We have asked our external consultants from the FDA's Anesthetic and Analgesic Pharmaceuticals Committees and Drug Safety and Risk Management Advisory Committees to explore options to increase access to naloxone.
As part of HHS 'ongoing efforts to combat the opioid crisis and develop the use of naloxone, the Department announced in April 2017 its five-point strategy to combat the opioid crisis. These efforts include: better prevention, treatment and recovery services for addictions; better data; better pain management; better targeting of drugs with overdose reversal; and a better search. In April 2018, VADM Surgeon General Jerome Adams issued an opinion encouraging more people, including family, friends and those at risk of opioid overdose to wear naloxone. In December 2018, Admiral Brett P. Giroir, MD, Assistant Secretary of Health and Senior Advisor to the Secretary for Opioid Policy, issued guidelines for health care providers and patients explaining how naloxone can help save lives.
We are taking many steps to improve the availability of naloxone products and we are committed to working with other federal, provincial and local officials. health care providers; the patients; and communities across the country to combat the high human and economic toll created by opioid abuse and addiction.
For more information:
FDA: Information on naloxone
The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety of food products, cosmetics, food supplements, products emitting electronic radiation and the regulation of tobacco products.
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SOURCE US Food and Drug Administration
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