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Thank you for visiting the Contemporary Pediatrics® website. Take a look at some of our top stories from last week (Monday, January 13, to Friday, January 17, 2025), and click on each link to read and watch anything you may have missed.
According to preliminary fourth-quarter 2024 financial results and objectives for 2025, the company has filed a supplemental New Drug Application (sNDA) with the FDA for a 1 mg dose of neffy for this weight group. The Prescription Drug User Fee Act target action date is set for March 6, 2025, and, pending approval, product availability is expected in the second quarter of 2025.
The FDA’s initial approval of neffy was based on pharmacokinetic data demonstrating comparable epinephrine blood concentrations achieved with the nasal spray versus approved epinephrine injection products. Four studies involving 175 healthy adults without anaphylaxis indicated that neffy produced similar increases in blood pressure and heart rate—key epinephrine effects for managing anaphylaxis.2
"Anaphylaxis is life-threatening, and some people, particularly children, may delay or avoid treatment due to fear of injections," said Kelly Stone, MD, PhD, associate director of the FDA’s Division of Pulmonology, Allergy and Critical Care, at the time of approval.2
Crenessity offers a novel therapeutic mechanism, targeting corticotropin-releasing factor type 1 (CRF1) receptors to reduce excessive ACTH and androgen production. Clinical trials demonstrated its potential to lower glucocorticoid doses while maintaining hormonal control, improving outcomes, and minimizing side effects. The CAHtalyst Pediatric Study (NCT04806451), published in The New England Journal of Medicine, revealed significant reductions in androstenedione and 17-OHP levels, as well as promising trends in body mass index, insulin resistance, and hirsutism.
To explore the implications of this approval, Kyriakie Sarafoglou, MD, lead investigator of the CAHtalyst Pediatric Study and professor at the University of Minnesota, shares insights into crinecerfont’s impact on the treatment landscape, key clinical data, and the vital role of general providers in managing pediatric CAH.
Click here for the full Q+A transcription with Sarafoglou.
"She's so constipated. I give her a laxative, and she eats fruit. What else can I do?" This familiar concern echoes through pediatric offices daily. While medications can be important in managing constipation, dietary interventions are equally critical and can significantly improve treatment success. This article explores practical strategies using the "3 Fs" of constipation management: Fiber, fluid, and fitness.
The FDA has revoked the authorization of red no. 3 in food and ingested drugs according to a January 15, 2025 announcement, with basis from the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The revoke of authorization follows a 2022 color additive petition that requested whether the Delaney Clause applied.
The 2022 petition cited various data including 2 studies that demonstrated cancer in laboratory male rats that were exposed to high levels of FD&C red no. 3. The FDA noted the way the dye causes cancer in male rats does not occur in humans, and that claims that the "use of red no. 3 in food and ingested drugs puts people at risk are not supported by the available scientific information," wrote the agency.
Read these quick comments from Donna Hallas, PhD, PPCNP-BC, CPNP, PMHS, FAANP, FAAN, and Bernard Cohen, MD, regarding the banning of red No. 3 from foods and ingested drugs.
Calling out signs of addictive behavior around social media or binge eating
January 17th 2025Susan Carnell, PhD, highlights the nuanced relationship between social media use and binge eating in adolescents, noting the importance of addressing addictive behaviors and seeking support when needed.
