FDA approves over-the-counter Narcan

FDA Approves First Over-the-Counter Naloxone Nasal Spray

Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. Today’s action paves the way for the life-saving medication to reverse an opioid overdose to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online.

About time.

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13 Responses to FDA approves over-the-counter Narcan

  1. Servetus says:

    Yes, it is about time. Speaking of time, ODs among people 65 or older have been on the rise since 2000. According to a study published by JAMA:

    29-MAR-2023 — Overdose mortality among people age 65 and older quadrupled over 20 years, suggesting the need for greater mental health and substance use disorder policies addressed at curbing the trend, a new research paper finds.

    The deaths stemmed from both suicides and accidental overdoses, with nearly three-fourths of the unintended fatalities involving illicit drugs such as synthetic opioids like fentanyl, heroin, cocaine, and methamphetamines. Prescription opioids, antidepressants, benzodiazepines, anti-epileptics and sedatives were used in 67% of intentional overdoses. […]

    Overall, they found that fatal overdoses quadrupled from 1060 in 2002 (3 per 100,000 population) to 6,702 (12 per 100,000) in 2021. The highest rates were among Blacks, at 30.9 per 100,000. […]

    “Even though drug overdose remains an uncommon cause of death among older adults in the U.S., the quadrupling of fatal overdoses among older adults should be considered in evolving policies focused on the overdose epidemic,” the researchers write. “Current proposals to improved mental health and substance use disorder coverage within Medicare, for example, applying mental health parity rules within Medicare, acquire greater urgency in light of this study’s results.” […]

    AAAS Public Science News Release: Drug overdose fatalities among US older adults has quadrupled over 20 years, UCLA research finds

    JAMA Psychiatry: Beneficiaries Before and During the COVID-19 Pandemic

    Christopher M. Jones, PharmD, DrPH; Carla Shoff, PhD; Carlos Blanco, MD, PhD; Jan L. Losby, PhD, MSW1; Shari M. Ling, MD; Wilson M. Compton, MD, MPE.

  2. Servetus says:

    Biosynthesis is being applied to hemp to increase its potential to produce other compounds besides THC and CBD, such as Cannabigerol (CBG) and Cannibinol (CBN):

    6-APR-2023 — In partnership with York University in Ontario, Canada, and the Institute for Advanced Learning and Research in Danville, Virginia, researchers in the College of Agriculture and Life Sciences received a $600,000 grant to study the regulation of the genes that are responsible for cannabinoid biosynthesis.

    “We’re interested in the regulation of the gene expression of the enzymes that are responsible for cannabinoid biosynthesis,” said Bastiaan Bargmann, an assistant professor in the School of Plant and Environmental Sciences. “We currently just don’t have a lot of knowledge about how the biosynthetic pathway is regulated.” […]

    To understand the regulation of the cannabinoid synthesis pathway in hemp (Cannabis sativa L.), researchers will map the relationship between factors that turn on or off the genes for enzymes, measure the effect of manipulating these factors, and engineer hemp cells and plants with the modified profiles.

    “If we can find ways to manipulate the biosynthesis so that, instead of these main ones (THC and CBD), we start to get other ones like CBG (Cannabigerol), CBN (Cannabinol), and others, then we can perhaps grow crops that have a greater economic value than the ones we currently have,” Bargmann said. […]

    AAAS Public Science News Release: Virginia Tech researchers to investigate transcriptional regulation of cannabinoid synthesis in industrial hemp

  3. Servetus says:

    Opioid prescriptions for those 65-or-older appear to be linked in some way to greater than normal reductions in cognitive functioning due to aging. This raises the possibility that substituting cannabinoids for opioids for pain relief might pose a remedy:

    18-APR-2023 — Prescription opioid use could have a negative effect on cognitive function in older adults, according to a recent Mayo Clinic study published in the Journal of the American Geriatrics Society. […]

    The study found that 70% of participants received at least one opioid prescription over an average of 7.5 years. Each prescription was linked to declines in cognitive performance, particularly in memory, language and attention. Those receiving opioids also had a 20% higher chance of developing mild cognitive impairment, a state of cognitive decline that exceeds normal aging. […]

    The researchers believe that the results of their study could lead to the development of more effective treatment strategies for older adults and help to mitigate the negative impact of prescription opioids on cognitive function.

    They note that the mechanisms by which opioids may lead to cognitive decline are not fully understood. The key question is whether observed associations between prescription opioids and cognitive decline show causal relationships, or whether prescription opioids are a marker for other conditions associated with cognitive dysfunction.

    “This data, while compelling, does not establish a causal link between prescription opioids and cognitive decline,” says Dr. Warner. “However, a clear association exists between opioids and long-term cognitive decline, which should spark conversation when considering whether to start an older adult on a prescription opioid.” […]

    AAAS Public Science News Release: Do prescription opioids impact cognitive function in older adults?

    “Prescription opioids and longitudinal changes in cognitive function in older adults: A population-based observational study,” — Nafisseh S Warner, Andrew C Hanson, Phillip J Schulte, Elizabeth B Habermann, David O Warner, Michelle M Mielke.

  4. Servetus says:

    Research done at the University of Oregon shows nematode worms’ cannabinoid systems cause them to respond to food the same as humans:

    20-APR-2023 — “Cannabinoids make nematodes hungrier for their favored foods and less hungry for their non-favored foods,” says Shawn Lockery from the University of Oregon in Eugene. “Thus, the effects of cannabinoids in nematodes parallels the effects of marijuana on human appetites.

    “Nematodes diverged from the lineage leading to mammals more than 500 million years ago,” he added. “It is truly remarkable that the effects of cannabinoids on appetite are preserved through this length of evolutionary time.”

    At the molecular level, the cannabinoid system in nematodes looks a lot like that in people and other animals. It begged the question as to whether the so-called hedonic feeding effects of cannabinoids also would be conserved across species.

    In the new study, the researchers first showed that worms react to the endocannabinoid anandamide by eating more. They also ate more of their favorite food. The researchers found that those effects of the endocannabinoids depended on the presence of the worms’ cannabinoid receptors.

    In further studies, they genetically replaced the C. elegans cannabinoid receptor with the human cannabinoid receptor to see what would happen, and they found that the animals responded normally to cannabinoids. The discovery emphasizes the commonality of cannabinoid effects in nematodes and humans, the researchers say. They report that the effects of anandamide also depend on neurons that play a role in food detection.

    “We found that the sensitivity of one of the main food-detecting olfactory neurons in C. elegans is dramatically altered by cannabinoids,” Lockery said. “Upon cannabinoid exposure, it becomes more sensitive to favored food odors and less sensitive to non-favored food odors. This effect helps explain changes in the worm’s consumption of food, and it is reminiscent of how THC makes tasty food even tastier in humans.” […]

    “Cannabinoid signaling is present in the majority of tissues in our body,” he said. “It therefore could be involved in the cause and treatment of a wide range of diseases. The fact that the human cannabinoid receptor gene is functional in C. elegans food-choice experiments sets the stage for rapid and inexpensive screening for drugs that target a wide variety of proteins involved in cannabinoid signaling and metabolism, with profound implications for human health.”

    The researchers note that big outstanding questions remain, including how cannabinoids change the sensitivity of C. elegans olfactory neurons, which don’t have cannabinoid receptors. They’re also curious to study the effects of psychedelics on nematodes. […]

    AAAS Public Science News Release: Cannabinoids give worms the munchies, too

    Current Biology: The conserved endocannabinoid anandamide modulates olfactory sensitivity to induce hedonic feeding in C. elegans

    Anastasia Levichev, Serge Faumont, Rachel Z. Berner, Zhifeng Purcell, Amanda M. White, Kathy Chicas-Cruz, Shawn R. Lockery

  5. Servetus says:

    Researchers at the University of Saskatchewan intend to test the use of CBD for pain relief for injured dogs.

    04 APR 23 — CBD use in pets has gained in popularity in the last decade, but there are few controlled studies closely examining its efficacy as a pain management tool. This study hopes to help partially close this knowledge gap.

    The research team, led by Dr. Alan Chicoine, Assistant Professor, Department of Veterinary Biomedical Sciences, will study the effect of CBD on pain relief in dogs undergoing tibial plateau leveling osteotomy (TPLO), a procedure used to treat cranial cruciate ligament tears. TPLO surgery is a common procedure in dogs and can be associated with significant discomfort.

    The team will assess the effect of adding CBD oil to the standard protocol used to manage postoperative pain in these patients. Dogs will be randomly assigned to either receive a placebo or CBD in addition to the standard pain control regime. Owners and their veterinarians will be blinded to their treatment group. Surveys and physical examinations will be used to assess pain, and the results will be compared between the two groups.

    “We need evidence to either support or refute the use of CBD in veterinary patients,” said Chicoine. “This study hopes to objectively answer whether, in this situation, CBD provides some benefit. If it does, we want to get that information out to the veterinary community. Then dog owners, in consultation with their family veterinarian, can decide if CBD is right for them.” […]

    Morris Animal Foundation: Newly Funded Morris Animal Foundation Study Assesses CBD Use for Postsurgical Pain in Dogs

    • Son of Sam Walton says:

      Fido needs his medical card too, I always say. A million times I’ve gone on long walks with the guy and he could never partake with me. But he’d chew and eat on bits and pieces of grass on our walk while his daddy would smoke his.

      P.S. I think our good buddy Duncan has been surfing out on Wall Street comment sections . . . his personality is noticeable, or there are two of him.

  6. Servetus says:

    Genetics plays a role in opioid addictions:

    27-APR-2023 — The study enrolled about 1,300 patients within three large urban emergency departments in Ohio, which has ranked in the top five for opioid overdose deaths since 2014.

    “We wanted to determine for any random person who comes to the emergency department what their genetic link might be and do they now or did they ever have opioid use disorder in their life, and do we think their genetics have played a role in that,” says Freiermuth. “We found that there were quite a few single nucleotide polymorphisms that seem to be associated with opioid use disorder.”

    The study found that although genetics play a role in disease, there is also significant interaction from the environment. […]

    AAAS Public Science News Release: University of Cincinnati research examines the role of genetics in opioid use disorder. Study identifies genetic variants that could provide therapeutic targets in the future

    Clinical Pharmacology and Therapeutics: Genetic Variants Associated With Opioid Use Disorder

    Caroline E. Freiermuth, David F. Kisor, Joshua Lambert, Robert Braun, Jennifer A. Frey, Daniel J. Bachmann, Jason J. Bischof, Michael S. Lyons, Michael V. Pantalon, Brittany E. Punches, Rachel Ancona and Jon E. Sprague

  7. darkcycle says:

    Shocker. Well, it fits with what we know already. A strong (stronger than I was willing to admit) genetic link, but requires some trauma coupled with exposure to drugs to trigger the addiction. Pretty much the same for everything.

  8. Servetus says:

    Modified or altered ibogaine molecules were tested in mice and showed reductions in addiction and depression symptoms:

    2-MAY-2023 — Scientists have developed two new drug candidates for potentially treating addiction and depression, modeled on the pharmacology of a traditional African psychedelic plant medicine called ibogaine. At very low doses, these new compounds were able to blunt symptoms of both conditions in mice…A team of scientists from UCSF, Yale and Duke universities virtually screened 200 million molecular structures to find ones that blocked SERT [serotonin transporter] in the same way as ibogaine.

    “Some people swear by ibogaine for treating addiction, but it isn’t a very good drug. It has bad side effects, and it’s not approved for use in the U.S.,” said Brian Shoichet, PhD, co-senior author and professor in the UCSF School of Pharmacy. “Our compounds mimic just one of ibogaine’s many pharmacological effects, and still replicate its most desirable effects on behavior, at least in mice.” […]

    Ibogaine is found in the roots of the iboga plant, which is native to central Africa, and has been used for millennia during shamanistic rituals. In the 19th and 20th centuries, doctors in Europe and the U.S. experimented with its use in treating a variety of ailments, but the drug never gained widespread acceptance and was ultimately made illegal in many countries.

    Part of the problem, Shoichet explained, is that ibogaine interferes with many aspects of human biology.

    “Ibogaine binds to hERG, which can cause heart arrhythmias, and from a scientific standpoint, it’s a ‘dirty’ drug, binding to lots of targets beyond SERT,” Shoichet said. “Before this experiment, we didn’t even know if the benefits of ibogaine came from its binding to SERT.” […]

    AAAS Public Science News Release: Ibogaine inspires new compounds to treat addiction, depression. Targeted molecules are more powerful than SSRI antidepressants and avoid ibogaine’s dangerous side effects

    Cell: Structure-based discovery of conformationally selective inhibitors of the serotonin transporter

    Isha Singh, Anubha Seth, Christian B. Billesbølle, Joao Braz, Ramona M. Rodriguiz, Kasturi Roy, Bethlehem Bekele, Veronica Craik, Xi-Ping Huang, Danila Boytsov,Vladimir M. Pogorelov, Parnian Lak, Henry O’Donnell, Walter Sandtner, John J. Irwin, Bryan L. Roth, Allan I. Basbaum, William C. Wetsel, Aashish Manglik, Brian K. Shoichet, Gary Rudnick.

  9. Servetus says:

    Psilocybin works by binding more strongly than serotonin to the 5-HT(2A)R serotonin receptor:

    2-MAY-2023 — Psilocybin is a hallucinogenic compound found in about 200 mushroom species, including the liberty cap (Psilocybe semilanceata)….The substance has the potential to revolutionize the way we treat conditions such as severe depression and substance addiction, according to many. This is also the opinion of University of Southern Denmark researchers Himanshu Khandelia and Ali Asghar Hakami Zanjani from the Department of Physics, Chemistry and Pharmacy. […]

    “My interest was piqued when I heard a podcast about treating smoking addiction with psilocybin. And since psilocybin mushrooms grow everywhere in Denmark – I picked some in Svanninge Bakker – it wasn’t difficult to start our research”, said Himanshu Khandelia.

    Together with Ali Asghar Hakami Zanjani, he is interested in understanding what happens at the molecular level when psilocybin enters the body, is converted to psilocin, and reaches the brain.

    “Previous research has shown that psilocin binds to serotonin receptors in the brain. We show that psilocin binds stronger than serotonin to a 5-HT(2A)R serotonin receptor. This knowledge can be used if you want to design a drug that acts like psilocybin,” explained Ali Asghar Hakami Zanjani. […]

    AAAS Public Science News Release: How hallucinogenic substance in psilocybin mushrooms works on the molecular level

    Biochimica et Biophysica Acta (BBA) – Proteins and Proteomics: The molecular basis of the antidepressant action of the magic mushroom extract, psilocin

    Ali Asghar Hakami Zanjani, Teresa Quynh Tram Nguyen, Luise Jacobsen, Himanshu Khandelia.

  10. Servetus says:

    Australian researchers surveyed 3,148 medicinal marijuana patients to get their assessments of the herb’s overall effectiveness with responses showing significant improvements in quality of life:

    9-MAY-2023 — In this case series of 3148 patients, 1688 (53.6%) were female; 820 (30.2%) were employed; and the mean (SD) age was 55.9 (18.7) years at baseline before treatment. Chronic noncancer pain was the most common indication for treatment (68.6% [2160 of 3148]), followed by cancer pain (6.0% [190 of 3148]), insomnia (4.8% [152 of 3148]), and anxiety (4.2% [132 of 3148]). After commencing treatment with medical cannabis, patients reported significant improvements relative to baseline on all 8 domains of the SF-36, and these improvements were mostly sustained over time. After controlling for potential confounders in a regression model, treatment with medical cannabis was associated with an improvement of 6.60 (95% CI, 4.57-8.63) points to 18.31 (95% CI, 15.86-20.77) points in SF-36 scores, depending on the domain (all P < .001). Effect sizes (Cohen d) ranged from 0.21 to 0.72. A total of 2919 adverse events were reported, including 2 that were considered serious. […]

    …patients using medical cannabis reported improvements in health-related quality of life, which were mostly sustained over time. Adverse events were rarely serious but common, highlighting the need for caution with prescribing medical cannabis. […]

    JAMA Network Open: Assessment of Medical Cannabis and Health-Related Quality of Life

    Thomas R. Arkell, PhD; Luke A. Downey, PhD; Amie C. Hayley, PhD; Sebastian Roth, PhD.

  11. Servetus says:

    The biology of heroin withdrawal symptoms has been revealed by researchers in South Carolina. Withdrawal is a motivator in drug seeking behavior. Eliminating it stops one link in the chain of events to heroin’s continued use:

    12-MAY-2023 — A team of neuroscientists at the Medical University of South Carolina (MUSC) has identified changes in the activity of brain cells known as pyramidal neurons, which contribute to drug seeking in a preclinical model of opioid use disorder. After access to heroin was stopped, these neurons became more excitable. The activity of these neurons was restored to normal by blocking the enzyme protein kinase A (PKA). Inhibiting this enzyme also reduced opioid-seeking behavior.

    “Prevention of return to use is the key in successful development of effective treatments for substance use disorders,” said Kokane.

    “After decades of research on opioid use disorder, three FDA-approved drugs exist, but they only reduce the severity of detoxification symptoms and don’t stop return to use. So, there is a definite need for more treatment options,” he said. “Currently, we lack a comprehensive understanding of the effects of opioids, like heroin, on the neurons that drive return to use. Better understanding these changes may lead to additional treatment options.” […]

    The McGinty Lab at MUSC identified specific types of pyramidal neurons that contribute to relapse. They found that these neurons in a specific brain region, the prelimbic prefrontal cortex, undergo molecular and functional changes during abstinence from heroin, a commonly used opioid, which disrupt its function. The prelimbic cortex is one of the areas of the brain involved in decision-making and behavioral control. Opioids can disrupt normal function in this part of the brain, and in someone with opioid use disorder, this interference can lead to compulsive drug seeking. […]

    AAAS Public Science News Release: Restoring control to a particular brain region may help to prevent return to use of opioids. Return to use of opioids after stopping is associated with heightened overdose risk — Medical University of South Carolina researchers have found a new way to reduce return to the use of opioids in a preclinical model.

    Journal of Neuroscience: Increased Excitability and Synaptic Plasticity of Drd1- and Drd2- expressing Prelimbic Neurons Projecting to Nucleus Accumbens after Heroin Abstinence are Reversed by Cue-induced Relapse and Protein Kinase A Inhibition

    Saurabh S. Kokane, Robert D. Cole, Bogdan Bordieanu, Chevin M. Ray, Ishraq A. Haque, James M. Otis and Jacqueline F. McGinty.

  12. Servetus says:

    Researchers in Bangkok, Thailand have developed an edible coating made from encapsulated CBD that can preserve freshness in strawberries:

    17-MAY-2023 — …To increase the berries’ shelf life, researchers reporting in ACS Applied Materials & Interfaces have incorporated cannabidiol — a non-hallucinogenic compound from cannabis known as CBD — and sodium alginate into an edible antimicrobial coating.

    CBD is popular because of its potential therapeutic effects. But this cannabinoid has also been shown to have antioxidant and antimicrobial properties. In previous studies, CBD limited the growth of some bacteria and pathogenic fungi, such as the ones that cause fresh fruits and vegetables to rot. However, the oily compound needs to be evenly distributed in water before it can be widely incorporated into foods or used for food preservation. One possible way to do this is to encapsulate the CBD molecules in edible polymers. So, Pongpat Sukhavattanakul, Sarute Ummartyotin and colleagues wanted to see if a food coating made using CBD-filled nanoparticles could promote antimicrobial activity and extend the freshness of strawberries.

    Untreated and treated strawberries were then placed in open plastic containers at refrigerator temperatures. After 15 days, CBD-treated samples ripened and decayed much more slowly than untreated ones, possibly because of reduced microbial growth. The coating with the most CBD-loaded nanoparticles preserved the berries’ dark red appearance, enhanced their antioxidant activity the most and exhibited the largest antimicrobial protection over the storage period, suggesting that this version would lead to the longest shelf life […]

    AAAS Public Science News Release: An edible CBD coating could extend the shelf life of strawberries

    ACS Applied Materials and Interfaces: Influence of a Transparent and Edible Coating of Encapsulated Cannabidiol Nanoparticles on the Quality and Shelf Life of Strawberries

    Pongpat Sukhavattanakul, Thanyaluck Thanyacharoen, Piyachat Chuysinuan, Supanna Techasakul, and Sarute Ummartyotin.

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