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Naloxone Can Prevent Opioid Overdose Deaths. Why Isn T The FDA Allowing Over-the-Counter Sales



Addressing opioid overdose continues to be one of the most urgent public health priorities for the U.S. government and making potentially lifesaving treatments more readily available is one of the top ways we can address this crisis. As we observe Prescription Opioid and Heroin Epidemic Awareness Week, a time when we acknowledge the devastating toll the opioid crisis has inflicted on our country, we felt it was essential to clarify important information about naloxone, an emergency opioid overdose reversal treatment. Naloxone is a critical tool for individuals, families, first responders and communities to help reduce opioid overdose deaths.




Naloxone Can Prevent Opioid Overdose Deaths. Why Isn t the FDA Allowing Over-the-Counter Sales



There is also a persistent misunderstanding that the FDA-approved labeling for the injectable form of naloxone, the least expensive option, precludes administration outside a health care setting. This has created confusion among public health officials and community-based organizations about whether the injectable form of naloxone can be used as part of their distribution programs. The FDA-approved product labeling for the three forms of naloxone does not exclude dispensing by pharmacies or community distribution programs. All three forms of naloxone are FDA-approved and may be considered as options for community distribution and use by individuals with or without medical training to stop or reverse the effects of an opioid overdose.


In April, we approved the first generic naloxone hydrochloride nasal spray, a generic of the brand product, Narcan. The FDA is also granting priority review to all generic applications for products that can be used as emergency treatment of known or suspected opioid overdose. As part of the priority review, sponsors will receive shorter goal dates or standard goal dates with earlier reviewer deadlines; enhanced agency communication with sponsors; and expanded agency engagement, such as pre-submission and mid-cycle meetings.


April: FDA hosted a scientific workshop to initiate a public discussion about the potential value of making naloxone available in the community to reduce the number of opioid overdose fatalities. In simple terms, naloxone, marketed under the trade name Narcan and others, reverses the effects of opioids.


April: On April 3, FDA approved Evzio (naloxone hydrochloride injection) for the emergency treatment of known or suspected opioid overdose. Naloxone is a medication that rapidly reverses the effects of opioid overdose. Evzio is the first auto-injector designed to deliver a dose of naloxone outside of a healthcare setting.


November: On November 18, FDA approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can temporarily stop or reverse the effects of an opioid overdose, including an overdose from heroin.


October: On October 5, the FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management to discuss naloxone products intended for use in the community, specifically the most appropriate dose or doses of naloxone to reverse the effects of life-threatening opioid overdose in all ages, and the role of having multiple doses available in this setting. The committees also discussed the criteria prescribers will use to select the most appropriate dose in advance of an opioid overdose event and the labeling to inform this decision, if multiple doses are available.


March: On March 29, through a cooperative agreement with the FDA, the Reagan-Udall Foundation hosted a public meeting, Naloxone Access: Answering Questions, to explore some of the most frequently asked questions about access to naloxone, a drug used to reverse opioid overdoses.


2014. April: On April 3, FDA approved Evzio (naloxone hydrochloride injection) for the emergency treatment of known or suspected opioid overdose. Naloxone is a medication that rapidly reverses the effects of opioid overdose. Evzio is the first auto-injector designed to deliver a dose of naloxone outside of a healthcare setting.


November On November 18, FDA approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can temporarily stop or reverse the effects of an opioid overdose, including an overdose from heroin.


October: On October 5, the FDA convened a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management to discuss naloxone products intended for use in the community, specifically the most appropriate dose or doses of naloxone to reverse the effects of life-threatening opioid overdose in all ages, and the role of having multiple doses available in this setting. The committees also discussed the criteria prescribers will use to select the most appropriate dose in advance of an opioid overdose event and the labeling to inform this decision, if multiple doses are available.


Naloxone can quickly restore normal breathing and save the life of a person who is overdosing on opioids. In 2017, over 47,600 people died from an overdose on opioid drugs, including prescription pain relievers, heroin, and fentanyl.1 Naloxone is a safe medication that is widely used by emergency medical personnel and other first responders to prevent opioid overdose deaths. Unfortunately, by the time a person having an overdose is reached, it is often too late.


Friends, family, and other bystanders can save lives with naloxone. Naloxone distribution programs give naloxone kits to opioid users, their friends and families, and others who may find themselves in a position to save the life of someone at risk of an opioid overdose.


Yes. There is no evidence of significant adverse reactions to naloxone.5 Administering naloxone in cases of opioid overdose can cause withdrawal symptoms when the person is dependent on opioids; this is uncomfortable without being life threatening.6, 7 The risk that someone overdosing on opioids will have a serious adverse reaction to naloxone is far less than their risk of dying from overdose.8, 9 Naloxone works if a person has opioids in their system and has no harmful effect if opioids are absent. Naloxone should be given to any person who shows signs of an opioid overdose or when an overdose is suspected.10


All systems used by first responders deliver the stated dose of naloxone and can be highly effective in reversing an opioid overdose. Naloxone comes in two FDA-approved forms: injectable and prepackaged nasal spray. Study findings released in March 2019 suggests that the FDA-approved naloxone devices produce substantially higher blood levels of naloxone than improvised nasal devices.11 These results suggest that the FDA-approved forms are preferable over non-FDA-approved forms.


A survey given to chronic pain patients receiving prescription opioids found that nearly 1 in 5 had experienced an overdose and more than half engaged in high-risk behaviors, including combining opioids with alcohol. While only 3% of patients surveyed reported having a naloxone prescription or being trained to deliver naloxone, nearly 40% had witnessed an overdose.16 Another study found 68% of participants recruited from syringe service programs, detoxification, or opioid treatment programs had witnessed an overdose but only 17% had a prescription for naloxone.17Co-Prescribing Naloxone to At-Risk PatientsNIDA-funded researchers are evaluating interventions to improve opioid prescribing practices, including the co-prescription of naloxone. An early study found that giving naloxone to patients on opioid therapy for chronic pain was associated with fewer opioid-related emergency department visits, especially among patients receiving high doses of prescription opioids. This study will help to inform implementation efforts that can increase access to naloxone.5


All 50 states and the District of Columbia have passed legislation to improve layperson naloxone access, and in most states, laypersons can receive naloxone from a pharmacy under a standing order (i.e., without an individual prescription) or its functional equivalent.25 In 2018, the U.S. Surgeon General called for heightened awareness and greater availability of naloxone.26 In 2019, the FDA issued a statement on its continued efforts to increase the availability of all approved forms of naloxone.27 Yet, an August 2019 CDC report revealed that too little naloxone is dispensed in many areas that need it most.10NIDA-funded studies are addressing key barriers and facilitators to naloxone access. Current projects include assessing the implementation of pharmacy-based naloxone access and its association with opioid-overdose mortality rates; programs to scale up overdose education and naloxone distribution in community settings, pharmacies, and justice settings; pharmacy-focused training to increase naloxone dispensing to patients who may be at risk for opioid overdose; and use of naloxone by law enforcement and its impact on referrals to treatment and on the rates of 911 use by witnesses of opioid overdose.


Preliminary findings from NIDA-funded research show promise for a wearable device that can administer a large dose of naloxone when the device detects overdose-induced respiratory failure.28 Early findings from other researchers suggest that a smartphone app may be able to identify breathing problems and other physical symptoms associated with acute opioid toxicity, providing an early warning that an opioid overdose reversal agent is needed.29


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