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Colleen Sloan, PA-C, RDN is a board-certified PA and registered dietitian. 

Articles

Distinguishing between food allergies and intolerances is crucial. 

Preventing deficiencies in pediatric food allergies

. He joined the brand in March of 2023 as an editor before being promoted to senior editor in January 2024. Fitch graduated from Youngstown State University in Youngstown, Ohio in 2020 with a degree in telecommunications and journalism. He started his career as a news and sports videographer before becoming an on-air sports anchor at the NBC-affiliated news station in Youngstown. Fitch briefly worked as a national content writer for a Chicago-based national television station before joining the 

team. He can be reached at: jfitch@mjhlifesciences.com.

If approved, the expanded indication would include children and adolescents aged 6 to 17 years who weigh 99 lbs (45 kg) or more. 

FDA accepts sBLA to expand fremanezumab-vfrm indication for episodic migraines in children

In the phase 3 TRANSCEND trial, setmelanotide met the primary endpoint of a statistically significant and clinically meaningful BMI reduction compared to placebo. 

Setmelanotide demonstrates BMI reduction in patients with acquired hypothalamic obesity

 and joined the MJH Life Sciences team in December 2019. She graduated from Youngstown State University in 2019 with a bachelor's degree in journalism and a minor in political science. Prior to graduating, Morgan worked as the editor-in-chief of her college newspaper. She went on to work as an assignment editor at a broadcast news station in Youngstown, Ohio before joining 

 You can reach her at mpetronelli@mjhlifesciences.com.

A new study published in JAMA Open Network suggests that early-life exposure to ambient ozone (O3) may contribute to an increased risk of asthma and wheeze in young children.

Early-life ozone exposure linked to increased risk of asthma and wheeze in young children

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Authors

Here is what pediatric health care providers need to know about this often debilitating disorder.

Diagnosis and treatment of cannabinoid hyperemesis syndrome

**Editor's Note** Please note that starting January 1, 2025, we will be switching to an online-exclusive publication process. This will allow us to publish case submissions quicker without having to deal with the variables that come along with print publication. All cases will still be eligible for print publication consideration, but publication in our print magazine is not guaranteed and will be up to the editor's discretion. 

Do you have a puzzling pediatric case that you’d like to share with the readers of 

We are looking for intriguing diagnoses that have stumped the experts—a diagnostic “Puzzler”—to help our physicians enhance their day-to-day practices. If you have such a story to tell, tell us.

Here’s what to do: Before you begin, we suggest that first you review the Puzzler 

https://www.contemporarypediatrics.com/case-studies

. Please note the specific style required for writing Puzzler manuscripts.

Next, prepare a draft of your case, including a summary of the presenting symptoms, a case overview, a 

table of the differential diagnosis (MANDATORY)

, and the special aspects of your case that qualify it as a Puzzler, and send it to us. Please note that the differential diagnosis table should also be discussed in the body text. We’ll review your draft and let you know what you need to add or revise before we send the manuscript to peer review for evaluation.

Puzzlers vary in length, and we suggest a minimum of 1,200 words up to a maximum of 2,000 words, but that is because of the complexity of some cases and whether some patients returned for many assessments before their diagnoses were determined. Also, some authors describe the pathophysiology of the differentials in great detail. Please also note no more than 3 authors are allowed per article.

What's most important is to show us the process that you used to analyze the case, including:

Why you decided to order certain tests and why you did not order others.

Peer consultations or why you elected to contact other specialists.

Lab values including vital signs or blood tests.

Labs and values if your patient was attended to in the emergency department or other hospital departments such as radiology or neurology.

Discussion related to the possible diagnoses.

Final diagnosis, treatment, prognosis, and follow-up.

Remember to indicate numbered citations within the body of the text and include a complete list of corresponding literature/references at the end of the manuscript. (Do not use any citation management programs or unlink them.) 

Limit references to 25. No references (unless it is a seminal study) can be older than 10 years.

We prefer primary research as references, but some cases are so obscure that authors will need to pull from a variety of sources. However, 

. Be advised that peer reviewers are adamant that the disease/disorder you describe was actually diagnosed and not determined by index of suspicion on the basis of ruling out various differentials. We use AMA11 as our publication style, which uses superscript citation numbers and a corresponding numbered reference list. Please create your citations and references in this style.  Check this recent article posted online at 

https://www.contemporarypediatrics.com/view/the-rx-of-adhd

 for examples of reference style. IMPORTANT NOTE WITH AMA 11TH EDITION: PLEASE PUT DOI OR WEBSITES/URLS AT THE END OF THE REFERENCE LINE.

When you send your draft manuscript, also 

. These image files must be high-resolution jpg or tiff files (minimum of 300 dpi) and as large in size as possible. We suggest a minimum of 7 horizontal inches. The images must be original photos with clear permissions to use, not images from copyrighted sources. Send as separate attachments with your e-mail submission; do not embed images into your manuscript document.

After we receive your manuscript, our editors and peer reviewers will review your draft and let you know if we accept your submission for publication. 

Puzzler is one of the departments for which we receive the most submissions, so it may be several months after submission before you receive feedback from us.

If we do accept your submission for publication, we will contact you with further instructions.

Send your submissions in Microsoft Word format to 

, via e-mail to mpetronelli@mjhlifesciences.com

Guidelines for PUZZLER, Contemporary Pediatrics

As of March 5, 2025, epinephrine nasal spray (neffy; ARS Pharmaceuticals) 1 mg is FDA approved to treat type I allergic reactions, including anaphylaxis, in children aged 4 years and older who weigh 33 to 66 lbs, according to an announcement from ARS Pharmaceuticals.

With the approval, neffy becomes the first and only needle-free epinephrine treatment indicated for younger children. The expanded indication into a younger population comes after the August 9, 2024, 

initial approval of neffy for adults and pediatric patients

Neffy 1 mg is expected to be available in the United States by the end of May 2025, stated ARS in the announcement.

“The availability of a needle-free epinephrine option for children is a breakthrough in the treatment of severe allergic reactions,” said David Fleischer, MD, section head of Allergy & Immunology and professor of Pediatrics at Children's Hospital Colorado, in a statement.

"Many people wait to administer epinephrine until symptoms progress or take antihistamines as a first line of defense because they are afraid of injection. neffy’s small, user-friendly design addresses these challenges, empowering people to actually carry epinephrine and act quickly and confidently during an allergic emergency. This innovation will likely significantly improve health outcomes and enhance quality of life," said Fleischer. 

According to ARS, approval of neffy 1 mg is based on pharmacokinetic and pharmacodynamic responses in both pediatric and adult patients that were consistent with epinephrine injection products. ARS noted children as young as 10 years of age can use neffy effectively by following instructions, based on human factor studies. 

With a shelf-life of 24 months at room temperature, and the tolerance to temperature exposures up to 122°F (50°C) on testing up to 3 months, neffy offers potency benefits for a longer period compared to EpiPens, according to a 

Contemporary Pediatrics' editorial advisory member Russell Libby, MD, FAAP, highlights 2024 FDA approval of epinephrine nasal spray (Neffy) in this video interview. 

Discussing FDA approved neffy with Russell Libby, MD, FAAP

"When you look at EpiPens, you have a real narrow window of temperatures where it stays stable. What does that mean? Well, sometimes it can become impotent, but more often, the potency just diminishes," said Libby, founder and president of Virginia Pediatric Group, 

published after neffy was originally approved.

"So you might get 90% or 70%, whatever it is. I don't think we have a lot of data on it, but we know that it is very specific to be stored within basically room temperature 60 to 90 degrees,” Libby explained. In contrast, neffy remains stable even in extreme conditions, providing a more reliable option for patients. 

The approval of neffy 1 mg comes nearly 2 months ARS announced in a financial report that a supplemental new drug application was filed with the FDA for younger indication. Neffy was approved a 

day early of the March 6, 2025 Prescription Drug User Fee Act target action date.

"Today’s FDA approval of neffy 1 mg marks a major milestone towards our efforts to transform the management of severe allergic reactions,” said Richard Lowenthal, president and CEO of ARS, in a statement. 

"Many children and caregivers fear needle-based auto-injectors, which can delay lifesaving treatment. neffy’s needle-free, easy-to-use design addresses this unmet need, offering families a long-awaited alternative," added Lowenthal. "With nearly 4 out of 10 US epinephrine prescriptions written for children under the age of 18—and nearly a third of those for children weighing 15 to 30 kilograms

 —we believe neffy 1 mg will improve access to a needle-free option for the treatment of severe allergies and reduce hesitation in treating this vulnerable group. It will also eliminate risks like accidental needle injuries to children or caregivers.”

In an effort to place neffy on the shelves of various school nurses offices in the United States, eligible schools could receive neffy through the neffyinSchools program from ARS, launched in January 2025, based on availability.

ARS launches program to provide free neffy in eligible K-12 schools

1. ARS Pharmaceuticals Announces FDA Approval of neffy® 1 mg (epinephrine nasal spray) for Type I Allergic Reactions, Including Anaphylaxis, in Pediatric Patients Weighing 15 to < 30 Kilograms. ARS Pharmaceuticals. March 5, 2025. Accessed March 6, 2025. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-announces-fda-approval-neffyr-1-mg 

2. Fitch, J. FDA approves neffy as first nasal spray to treat anaphylaxis. 

. August 9, 2024. Accessed March 6, 2025. https://www.contemporarypediatrics.com/view/fda-approves-neffy-as-first-nasal-spray-to-treat-anaphylaxis 

3. Fitch, J. Discussing FDA approved neffy with Russell Libby, MD, FAAP. 

. January 1, 2025. Accessed March 6, 2025. https://www.contemporarypediatrics.com/view/discussing-fda-approved-neffy-with-russell-libby-md-faap 

4. Fitch, J. ARS launches program to provide free neffy in eligible K-12 schools. 

. January 22, 2025. Accessed March 6, 2025. https://www.contemporarypediatrics.com/view/ars-launches-program-to-provide-free-neffy-in-eligible-k-12-schools 

The newly-approved indication is for children aged 4 years and older who weigh 33 < 66 lbs, expanding on the August 9, 2024 approval in children at least 66 lbs. 

News

FDA approves neffy 1 mg for anaphylaxis in children aged 4 years and older

Positive data from an open-label extension (OLE) study of Viaskin Peanut patch (VP250; DBV Technologies) has demonstrated continued improvement in treatment benefit among peanut-allergic toddlers aged 1 to 3 years through 36 months, according to an announcement from DBV.

The OLE study followed the phase 3 EPITOPE trial (NCT03211247), which evaluated safety and efficacy of Viaskin Peanut patch 250 µg. In the EPITOPE trial, 67% of individuals in the treatment arm met the treatment responder criteria at 12 months, compared to 33.5% of those in the placebo are (difference in response rates = 33.4%; 95% CI = 22.4% - 44.5%), respectively.

A treatment responder was defined as either an individual with an eliciting dose (ED) ≤10 mg who reached an ED ≥300 mg of peanut protein at month 12, or an individual with a baseline ED >10 mg who reached an ED ≥1,000 mg of peanut protein at month 12.

According to previously-announced data from DBV, the EPITOPE trial enrolled 362 children aged 1 to 3 years, of which 244 and 118 were in the active and placebo arms, respectively.

After completion of the 12 month EPITOPE trial, eligible participants could enroll in the OLE to receive a total of 36 months of treatment. Double-blind placebo-controlled food challenges (DBPCFC) were conducted at the end of each year of treatment with safety assessed throughout the entire OLE, stated DBV.

Participants "remained blinded to their treatment assignment in EPITOPE until every patient completed EPITOPE and the database was locked; therefore, the decision to enter the OLE was not biased by the unblinding of the randomized treatment," noted DBV in the announcement.

RELATED: A discussion of epicutaneous immunotherapy for peanut allergic toddlers

Overall, 266 participants who completed EPITOPE enrolled in the OLE. Of these, 211 underwent the month 36 DBPCFC (n = 149 VP250; n = 62 placebo). After 36 months' treatment with Viaskin, 83.5% of participants reached an ED of ≥1000 mg, an increase from 64.2% at month 12 (the EPITOPE study).

Similarly, an increase was observed for those reaching an ED of ≥2000 mg, with 72.7% at month 36 and 37.0% at month 12, respectively.

Those who completed the DBPCFC without meeting stopping criteria increased from 30.7% at month 12 to 68.2% at month 36. A continued reduction in DBPCFC reaction severity occurred, with 66.5% having mild or no symptoms at month 36 vs 40.2% at month 12.

The data follows a December, 2024 announcement from DBV regarding alignment with the FDA on a regulatory pathway for Viaskin in those aged 1 to 3 years. The FDA formalized guidance on an Accelerated Approval for the patch, with each party having agreed on key design elements for a post-marketing confirmatory study.

According to DBV, Accelerated Approval criteria  includes

That the product candidate treats a serious condition

That the product candidate generally provides a meaningful advantage over available therapies

That the product candidate demonstrates an effect or an intermediate clinical endpoint that is reasonably likely to predict clinical benefit

1. DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3 Open-Label Extension Study. DBV Technologies. January 8, 2025. Accessed January 9, 2025. https://dbv-technologies.com/press_releases/dbv-technologies-announces-positive-3-year-results-from-epitope-phase-3-open-label-extension-study/

2. DBV Technologies Announces Positive Topline Results from Phase 3 EPITOPE Trial of Viaskin Peanut in PeanutAllergic Toddlers. DBV Technologies. June 7, 2022. Accessed January 9, 2025. https://dbv-technologies.com/wp-content/uploads/ir/epitope-press-release-pdf.pdf

3. DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin

 Peanut Patch in Toddlers 1 – 3 Years-Old.  DBV Technologies. December 11, 2024. Accessed January 9, 2025. https://dbv-technologies.com/press_releases/dbv-confirms-alignment-with-u-s-fda-on-accelerated-approval-pathway-for-the-viaskin-peanut-patch-in-toddlers-1-3-years-old/

In an open-label extension of the EPITOPE phase 3 trial, the Viaskin Peanut patch had continued improvement in toddlers aged 1-3 years through 36 months. 

New data: Viaskin Peanut patch improves treatment benefit through 36 months

The FDA has approved meningococcal ABCWY (MenABCWY, Penmenvy; GSK) vaccine for use in individuals aged 10 to 25 years, according to an announcement from GSK.

The vaccine targets 5 groups of the bacteria 

The combination vaccine targets 5 groups of the bacteria Neisseria meningitidis (A,B,C,W, AND Y) that cause the most invasive meningococcal disease cases (IMD) globally.

Jessica Calihan, MD

Articles

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