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GAO-19-706SP 1 (2019-09-16)

handle is hein.gao/gaobadzzf0001 and id is 1 raw text is: Science, Technology Assessment, GAO Iand Analytics SCIENCE & TECH SPOTLIGHT: OPIOID VACCINES What is it? Opioid vaccines are medical therapies designed to block opioids, such as heroin and fentanyl, from entering the brain or spinal cord, thus preventing addiction and other negative effects. While none are approved for use yet, they could be useful for at-risk individuals, patients in drug recovery programs, or first responders who might accidentally come into contact with deadly opioids that can be absorbed through the skin. This approach offers advantages over some current treatment methods, including requiring minimal medical supervision and no potential for abuse. Source: GAO. I GAO-19-706SP When an opioid enters the bloodstream (top), it crosses into the brain, where it can act on the target receptor to cause psychotropic effects, addiction, and overdose. Opioid vaccines (bottom) trigger the body to create antibodies that bind to opioid molecules and prevent them from entering the central nervous system, thus preventing negative effects. How does it work? When opioid molecules bind to receptors in the central nervous system (the brain and spinal cord), they can cause psychotropic effects (e.g., hallucination, euphoria), addiction, and overdose. Opioid molecules have specific chemical structures. Opioid vaccines are designed to trigger an immune response to these structures when injected into a patient. Similar to vaccines for infectious diseases, such as polio or measles, when a patient is treated with an opioid vaccine, their immune system learns to identify the targeted opioid as a dangerous foreign substance so it can respond if that opioid enters the bloodstream in the future. After the body has learned to target an opioid molecule, it naturally forms antibodies that can bind to it. These opioid-specific antibodies stick to opioid molecules in the bloodstream, forming a unit that is too large to enter the central nervous system. Without entering the central nervous system, the molecule is not able to produce the negative effects associated with opioids. The antibody-bound opioid will eventually be excreted via urine without harming the exposed individual. How mature is it? As of 2019, the Food and Drug Administration (FDA) has not approved any opioid vaccines for use. While opioid vaccine studies were initially proposed as early as the 1970s, clinical trials have thus far been unsuccessful. Currently, at least three early-stage clinical trials of potential opioid vaccines are underway, including one that the Walter Reed Army Institute of Research is conducting on a heroin vaccine. Recently the National Institutes of Health and the National Institute of Allergy and Infectious Diseases released a broad agency announcement to fund the development of opioid vaccines against heroin and fentanyl. This funding is set to begin in August 2020. Other academic researchers continue to publish studies focusing on development and preclinical testing of opioid vaccines. Treat at-risk patients. Unlike some current treatment options, opioid vaccines do not carry the risk of abuse. This could allow for more effective treatment of patients at high risk of abusing another medication, such as methadone. Medical advantages. The vaccines have a long duration (months to years) of action and require limited medical supervision. Compatible with other therapies. Vaccines currently in development are targeted to illicit use of opioids such as heroin and fentanyl, and therefore do not interfere with most drug treatment or pain management therapies. Protection against accidental exposure. Vaccines could be administered prophylactically to individuals at risk of accidental exposure to opioids, such as law enforcement, military, and first responders. Lack of broad-based effect. Current opioid vaccines are designed against the specific chemical structure of each opioid; therefore, multiple vaccines would be needed to provide broad-spectrum GAO-19-706SP Opioid Vaccines

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