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Amneal Pharmaceuticals announced on April 24, 2024, that the US Food and Drug Administration (FDA) approved the over-the-counter naloxone hydrochloride nasal spray for emergency treatment of an 

The approval followed an Abbreviated New Drug Application (ANDA) for naloxone hydrochloride (Naloxone HCI) nasal spray at 4mg. This is the generic equivalent to the Narcan HCI Nasal Spray, a medication used to treat drug overdose from opioids, such as heroin, fentanyl, and prescription opioid medications. 

 in March 2023 for nonprescription, over-the-counter use.

The generic equivalent has the same active ingredient and dose as Narcan Naloxone HCI Nasal Spray.

 Naloxone HCI nasal spray 4 mg rapidly reverses the effects of an opioid emergency by binding to opioid receptors and reversing or blocking the effects of opioids. The spray helps restore breathing to normal within 2 to 3 minutes, regardless of if the breathing just slowed or stopped due to the overdose.

More than two-thirds of all drug overdose deaths in 2022 included illicit synthetic opioids like fentanyl. For people under 50, overdose leads to more deaths than heart disease, cancer, homicide, suicide, and other accidents. The Centers for Disease Control and Prevention (CDC) reported about 46% of overdose deaths have another person present—a person who can intervene.

Although Narcan Naloxone HCl Nasal Spray 4mg was on the market, it cost a lot. The annual commercial sales ending in February 2024 were $266 million.

Amneal Naloxone HCI Nasal Spray is now available on the market. People may experience symptoms when they wake up, including shaking, sweating, nausea, or anger.

“Amneal is proud to help address this public health emergency by providing naloxone nasal spray at an affordable price and without a prescription,” said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal, in a press release. “By enhancing access to naloxone nasal spray, we hope to get this affordable emergency treatment into the hands of even more people who could potentially save countless families and communities from further heartache and loss.”

Amneal Announces U.S. FDA Approval of Over-the-Counter Naloxone Hydrochloride Nasal Spray for Emergency Treatment of an Opioid Overdose. 

https://www.morningstar.com/news/business-wire/20240424236083/amneal-announces-us-fda-approval-of-over-the-counter-naloxone-hydrochloride-nasal-spray-for-emergency-treatment-of-an-opioid-overdose

Campbell, P. FDA Approves Narcan Nasal Spray for Over-the-Counter Use. HCPLive. March 29, 2023. 

https://www.hcplive.com/view/fda-approves-narcan-nasal-spray-for-over-the-counter-use

Articles

FDA approves the generic equivalent of Narcan HCI Nasal Spray—naloxone hydrochloride (Naloxone HCI)—for an emergency treatment option for an opioid overdose.

News

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Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Addiction

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FDA Approves Over-the-Counter Naloxone Nasal Spray for Opioid Overdose

Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

 web search volume saw an increase between 2019 - 2023 in 21 European countries, according to recent findings, with correlations observed between web search volume and climates with humid, cold, and windy weather.

These findings and more were the results of new research conducted to evaluate atopic dermatitis-related searches on the Internet across various European countries, with the overall goal being an assessment of spatiotemporal variations and links between external and disease-related factors.

This new research was led by Hannah Wecker, from the department of dermatology and allergy at Technical University’s TUM School of Medicine and in Munich, Germany. Wecker et al. noted that crowdsourced web data regarding atopic dermatitis has been identified previously in single countries as well as globally, though the latter was to evaluate the popularity of search terms.

“The aim of the study was to investigate (atopic dermatitis)-related web searches in 21 different European countries to identify possible regional and seasonal variations, as well as associations between web searches and disease-related and external factors such as socioeconomic and meteorological data,” Wecker and colleagues wrote.

The investigators implemented a retrospective longitudinal study design in which they utilized Google Ads Keyword Planner for the purposes of gathering Internet search data that related to eczema or atopic dermatitis across 21 different countries in Europe.

These included Bosnia and Herzegovina, Croatia, Austria, Ireland, Czechia, Denmark, Sweden, Germany, France, Hungary, Greece, Italy, Malta, Portugal, Netherlands, UK, Poland, Serbia, Romania, Ukraine, and Spain. The Planner had originally been used for marketing but has since become a commonly-used tool for medical research.

The research team entered specific terms for their searches such as “atopic dermatitis” and “atopic eczema,” in addition to the terms’ lay equivalents. They did this using the respective native languages of each country, seeking to capture the wide variety of Internet searches and contribute to the ongoing dialogue regarding the most useful terminology for atopic dermatitis.

The team implemented professional translators and AI-based tools as needed with the goal of maintaining accurate translations across the various languages used in searches. Their country selection had been based upon expert input and the goal was to allow for comprehensive representation.

Data were gathered by the investigators such as keywords as well as monthly search volumes, and these were all assessed in the period between February 2019 - January 2023, with the research team normalizing the data per 100,000 inhabitants for their comparative analysis. They also explored spatiotemporal patterns and associations that could be identified between trends in searches as well as different factors related to socioeconomic indicators, prevalence of disease, and meteorological conditions.

More than 241 million web searches were evaluated by the research team regarding atopic dermatitis statistics, demonstrating substantial variation as far as search volume across the various European countries (

 < .001). The observed variation noted by the team was also shown to correlate with atopic dermatitis prevalence as well as burden of disease (both r = .51, 

The investigators reported there had been an increase in web search volume in the timeframe between 2019 - 2023 across all countries, noting that peaks typically took place in January and in March. Furthermore, the team found that there had been negative correlations between volume and median age of population (r = −.46, 

 = .039), in addition to the number of general practitioners (r = −.29, 

 = .226) and number of specialists (r = −.27, 

The research team also highlighted factors related to weather as playing a role, expressing that moderate to strong correlations were observed between volume and humid, cold, and windy climate conditions with fewer hours of sunlight. The team added that, typically, higher online interest would follow 1–3 months after these weather patterns.

“Using crowdsourced data offers versatile opportunities to gain further insights into this complex dermatological condition, such as monitoring search behavior for developments due to climate change or uncovering unmet needs in the population,” they wrote. “The seasonal trend in web searches for AD coincides with the seasonal exacerbation of AD during cold and humid weather, emphasizing the necessity for intensified public health campaigns…and adjustment of treatment plans during these periods.”

Wecker H, Ziehfreund S, Sitaru S, Johansson EK, Elberling J, Doll A, et al. Burden of atopic dermatitis in Europe: A population-centred approach leveraging web search data in 21 European countries. J Eur Acad Dermatol Venereol. 2024; 00: 1–12. https://doi.org/10.1111/jdv.19989.

Xu S, Thyssen JP, Paller AS, Silverberg JI. Eczema, atopic dermatitis, or atopic eczema: analysis of global search engine trends. Dermatitis. 2017; 28(4): 276–279.

This analysis highlighted several trends in search volume regarding eczema, including correlations with weather and climate.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

Atopic Dermatitis

Atopic Dermatitis condition center page, resources on the topics of medical news and expert insight into eczema can be found. Content includes articles, interviews, videos, podcasts, and breaking news on dermatitis research, treatment, and drug development.

Study Highlights Trends in Atopic Dermatitis Web Search Volume in Europe

Credit: Northwestern University Feinberg School of Medicine.

A new study underscores the significant impact of chronic skin disorders on children’s 

, revealing an association between disease variability, severity, and increased stigma, prompting a call for comprehensive clinical approaches.

Although chronic skin disorders in children often lead to stigmatization, the extent of stigmatization from chronic skin disease needed to be further examined. Investigators sought to examine the degree of the stigma depending on the disease's visibility and severity, alongside its impact on the mental well-being and quality of life of affected children.

“Skin disorders are often regarded as less serious than other groups of disease by the public, insurers, and pharmaceutical industry,” wrote investigators, led by Amy S. Paller, MD, from the departments of dermatology and pediatrics at Northwestern University Feinberg School of Medicine. “However, a child or adolescent with a chronic skin disorder risks becoming the target for bullying, alienation, and feelings of reduced self-worth, leading to stigma.”

The team conducted a cross-sectional, single-visit study at 32 pediatric dermatology centers in the US and Canada from November 14, 2018, to November 17, 2021. The primary outcome was the extent of stigma along with child, caregiver, and physician-assessed disease visibility. The secondary outcomes included assessing the association between stigma and disease severity, reduced quality of life, depression, anxiety, and poor peer relationships.

Quality of life was measured with the Skindex-Teen, reporting physical symptoms of skin pain, burning/stinging, itching, effect on sleep, and skin bleeding, and through the 16 items on the psychosocial functioning subscale.

The sample included 1671 children aged 8 – 17 years with a chronic skin disease, as well as 1 parent. Of the children, more than half were female (57.9%) and White (56.4%), with a mean age of 13.7 years.

The most common physician-determined diagnoses were acne (22.8%), AD/eczematous disorders (22.5%), alopecia (11.3), and psoriasis (7.4%). Children also had rarer disorders such as ichthyoses (2.1%) and EB (1%). Half of the participants reported high disease visibility (56.4%) and moderate disease severity (50.5%).

The skin disorders with the greatest percentage of children reporting high visibility were acne (74.5%) and dermatomyositis/lupus (75%). The disorders with the greatest reported severity were hyperhidrosis (55.6%), EB (33.3%), and AD (32.4%).

The team observed stigma scores significantly differed based on disease visibility and severity. Among children with chronic skin disorders—particularly acne, atopic dermatitis, alopecia areata, and vitiligo—only 27% had T scores < 40 indicating minimal or no stigma and 43.8% had a T score of ≥ 45 revealing moderate stigma.

Investigators saw stigma scores were associated with reduced quality of life (Spearman, 

 = -.49). However, the association did not reach significance.

The findings suggest stigma was associated with bullying (Cohen 

 = .79). Bullying took place primarily at school (94%) and was less frequent somewhere else in public such as parks, camps, or stores (12%), online (5%) or at home (4%).

Additionally, girls reported greater stigma than boys (Cohen 

 = .26). Children with hyperhidrosis and hidradenitis suppurativa were most likely to have increased depression and anxiety.

Investigators noted depression and anxiety were significantly associated with stigma for most skin disorders, such as hidradenitis suppurativa (depression, r = 0.67; anxiety, r = 0.70; both

 < .001). However, hyperhidrosis had a weak association between anxiety and depression (depression, r = 0.31; anxiety, r = 0.34).

Investigators highlighted several limitations, including needing more studies of children from middle-income and lower-income countries and the lack of validated severity assessment tools. Additionally, the study needs to be replicated with a larger sample.

Overall, investigators highlight physicians treating children with chronic skin disease should be aware of potential stigmatization.

“While successfully treating the underlying skin disease is a goal, other tools to diminish stigma include discussions with teachers; educating about the child’s disorder in the classroom; active discussions with the child about handling, recognizing, and managing bullying; and managing the psychosocial impact of stigma (eg, referral to psychiatry/psychology for interventions),” investigators wrote.

Programs exist for other chronic diseases, such as mental illness, genetic disorders, and HIV to help the development of resilience. Group sessions can be useful in identifying coping strategies, strengthening relationships, and creating a healthy living environment to reduce stigma.

“Key strategies for tackling perceived stigma include becoming aware of self-stigmatizing thoughts and learning to change these feelings and behaviors,” investigators concluded.

Paller AS, Rangel SM, Chamlin SL, et al. Stigmatization and Mental Health Impact of Chronic Pediatric Skin Disorders. 

. Published online April 24, 2024. doi:10.1001/jamadermatol.2024.0594

The extent of stigma significantly differs based on disease visibility and severity among children with chronic skin disorders.

Pediatrics

Pediatrics page, resources on the topics of medical news and expert insight into childhood health care can be found. Content includes articles, interviews, videos, podcasts, and breaking news on pediatric disease research, treatment, and drug development.

Pediatric Study Reveals Link Between Skin Disorder Visibility and Stigma

In recent years, few topics have attracted the same level of attention in cardiovascular medicine, particularly among lipidogists, as the evolving recognition of lipoprotein(a) [Lp(a)] as a marker of elevated risk. This evolving recognition of risk is happening in tandem with a growing knowledge base and burgeoning therapeutic pipeline. 

In 2019, the National Lipid Association released a scientific statement on using Lp(a) in clinical practice. Fast-forward a half-decade to April 01, 2024, and the NLA has released an update to this statement further clarifying recommendations surrounding the use of Lp(a) in clinical practice. A 12-page document citing more than 80 references, the recommendations and insights are the subject of a 3-part clinical quiz series from HCPLive Cardiology. 

The second quiz of the series, this quiz focuses on the basics surrounding recommendations for patients. 

Patients with a family history of cardiovascular disease

Switch to a different lipid-lowering drug

Koschinsky ML, Bajaj A, Boffa MB, et al. A focused update to the 2019 NLA scientific statement on use of lipoprotein(a) in clinical practice. 

. Published online March 29, 2024. doi:10.1016/j.jacl.2024.03.001

Editor's note: This quiz was composed with the assistance of artificial intelligence tools. 

The second in our 3-part quiz series based on the NLA's 2024 update to their 2019 scientific statement on use of lipoprotein(a) in clinical practice focuses on recommendations for patients.

Dyslipidemia

Clinical Quiz: Lp(a) Recommendations for Patients from 2024 NLA Update on Use of Lipoprotein(a)

Connor Iapoce is an associate editor for 

 and joined the MJH Life Sciences team in April 2021. He graduated from The College of New Jersey with a degree in Journalism and Professional Writing. He enjoys listening to records, going to concerts, and playing with his cat Squish. You can reach him at 

Eyenovia has provided an update on the phase 4 study of tropicamide and phenylephrine hydrochloride ophthalmic spray (Mydcombi) 1%/2.5% for 

Announced on April 25, 2024, the phase 4 study was designed to characterize the efficacy and duration of effect of the lowest deliverable dose for pupil dilation (8 µL per eye). The findings highlighted that approximately two-thirds of patients could achieve clinically relevant pupil dilation at 30 minutes post-dose.

“The results of this study highlight the favorable efficacy and tolerability of Mydcombi dispensed through the Optejet®. Notably, dilation was already dissipating by 3.5 hours post-instillation, which is similar to published studies of dilating eye drops followed by the use of a mydriasis reversal agent,” Michael Rowe, chief executive officer of Eyenovia, said in a statement.

Mydcombi was approved by the US Food and Drug Administration (FDA) in May 2023, representing the first approved fixed-dose combination of tropicamide and phenylephrine for inducing mydriasis for diagnostic procedures and short-term pupil dilation.

 Its approval also marked the first product approved by any regulatory authority to use the company’s proprietary Optejet® device.

Previously, in October 2021, the company received a Complete Response Letter (CRL) from the FDA to their New Drug Application (NDA) for Mydcombi, requesting additional device testing related to the Optejet® dispenser.

 The resubmitted NDA for MydCombi was accepted by the FDA in December 2022 and was supported by the completed phase 3 MIST-1 and MIST-2 clinical trials.

For this phase 4 study, 29 individuals were treated with a half-dose of Mydcombi State University of New York School of Optometry and evaluated at the end of 2023. Results showed pupil dilation was achieved in 67% of patients at 30 minutes post-dose.

By the 60-minute mark, investigators found the percentage of pupil dilation increased to 86%. Most patients returned to a pupil size of <5mm between 3.5- and 6 hours post-instillation, with 93% meeting that point at the 6-hour mark. Safety data indicated the administration of a lower 8 µL volume was well-tolerated and minimal adverse events were reported.

Current mydriatic eye drops utilized in eye examinations are limited by several factors, including the potential for cross-contamination, difficulty instilling in those with limited mobility, and often, tolerability and safety issues.

 At higher levels, phenylephrine has been found to cause serious systemic cardiovascular side effects in older individuals, particularly those with high blood pressure.

The full data set highlighting the favorable efficacy and tolerability of Mydcombi is expected to be presented at an upcoming medical meeting this year, according to Eyenovia.

“These results suggest that for patients in which the lowest deliverable dose of tropicamide and phenylephrine may be desired, the precision and flexibility of the Optejet technology may be an option for eye care professionals and their patients,” Rowe added.

Eyenovia provides clinical and scientific update on FDA-approved products MydcombiTM and Clobetasol Propionate Ophthalmic Suspension. Eyenovia Inc. April 25, 2024. Accessed April 25, 2024. https://ir.eyenovia.com/news-releases/news-release-details/eyenovia-provides-clinical-and-scientific-update-fda-approved.

Iapoce C. FDA approves fixed-dose ophthalmic spray for Mydriasis. HCP Live. May 8, 2023. Accessed April 25, 2024. https://www.hcplive.com/view/fda-approves-fixed-dose-ophthalmic-spray-mydriasis.

K Lodhi SA, Ramsali MV, Kulkarni DK, Surender P, Murty S. Safety of tropicamide and phenylephrine in pupillary mydriasis for cataract surgery. Saudi J Ophthalmol. 2022;35(2):108-111. Published 2022 Feb 18. doi:10.4103/1319-4534.337859

Eyenovia assessed the duration of effect of the lowest deliverable dose of tropicamide and phenylephrine hydrochloride ophthalmic spray 1%/2.5% in a phase 4 study.

Ophthalmology

Ophthalmology page, resources on the topics of medical news and expert insight into ophthalmic disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on eye disease research, treatment, and drug development.

Mydcombi Effective, Tolerable at Lowest Deliverable Dose for Mydriasis

New phase 3b/4 trial data compared both drugs efficacy and safety profiles for eczema patients, looking at adults and adolescents.

Upadacitinib Superior in Efficacy to Dupilumab for Atopic Dermatitis in Head-to-Head Study

Abigail Brooks is an assistant editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

Tenofovir disoproxil fumarate was safe and effective for preventing mother-to-child transmission of HBV, but discontinuation was linked to postpartum hepatitis flares. 

Hepatology

Hepatitis C

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Postpartum Hepatitis Flare Risk Increases After Discontinuation of Antiviral Therapy

Patrick Campbell is the managing editor of HCPLive. Formerly the editorial lead of Endocrinology Network, Practical Cardiology, and Rheumatology Network, Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. He now helps to lead coverage in each of these respective areas for HCPLive. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter with the Pocono Record in Stroudsburg, PA, and Star News Group in Manasquan, NJ. He also touts experience in multimedia, having spent time as a multimedia specialist with NJ Advance Media and multimedia coordinator at the Pocono Record. Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

A retrospective study challenges preoperative withholding of GLP-1 RAs in diabetes patients undergoing surgery, citing no increased risk of postoperative respiratory complications.

Type 2 Diabetes

Endocrinology

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Surgery

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Pulmonology

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

GLP-1 Receptor Agonists Not Linked to Post-Op Respiratory Complications

Videos

Chun spoke in this interview segment about more recommendations for internal medicine physicians to give older adults related to aging, dementia, and statin use.

Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

Audrey Chun, MD: Recommendations on Statins, Connecting Dementia to Hearing Loss

The fracture risk is greater for nursing home residents with dementia, greater baseline blood pressure values, and no recent antihypertensive medication use, a new study found.

Geriatrics

Geriatric medicine condition center page is a comprehensive resource for clinical news and insights on frequent geriatric-related diseases and conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for sleep disorder, dementia, Alzheimer's disease, and more.

Antihypertensive Medication Linked to Fracture Risk Among Older Adults

Solomon discusses the health care system’s role in mitigating climate change and how health care professionals can help protect and inform their patients.

Caren Solomon, MD, MPH: How The Health Care System Can Combat Climate Change

Lana Pine is the editor of HCPLive Rheumatology. She is an experienced editor and technical writer with a demonstrated history of working in the banking and publishing industries. In her free time, she enjoys cooking, yoga, listening to podcasts, and drawing. She can be reached via email at LPine@mjhlifesciences.com.

Patients receiving abatacept experienced smaller increases in mean IMT, max IMT, and plaque score compared with the csDMARD cohorts. 

Rheumatoid Arthritis

The HCPLive rheumatoid arthritis page is a comprehensive resource for clinical news and insights on arthritis. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for RA, and more.

Abatacept Treatment May Slow Atherosclerosis Progression 

Article intelligence chatbots, including ChatGPT and Bard, varied in accuracy, comprehensiveness, and readability on glaucoma questions adapted from patient brochures. 

AI Chatbots Show Promise as Patient Information Source for Glaucoma

At the end of the trial, the study met its primary outcome, indicating therapeutic equivalence between the biosimilar (AVT05) and reference golimumab. 

Biosimilars

Proposed Golimumab Biosimilar AVT05 Meets Primary Endpoints in Moderate to Severe RA 

An observational study in the UK investigated the risk of adverse events related to colchicine prophylaxis after receiving allopurinol for gout.

Gout

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Latest News

FDA Approves Over-the-Counter Naloxone Nasal Spray for Opioid Overdose

Study Highlights Trends in Atopic Dermatitis Web Search Volume in Europe

Pediatric Study Reveals Link Between Skin Disorder Visibility and Stigma

Clinical Quiz: Lp(a) Recommendations for Patients from 2024 NLA Update on Use of Lipoprotein(a)

Mydcombi Effective, Tolerable at Lowest Deliverable Dose for Mydriasis