How to talk with parents about the recent Pfizer/BioNTech news for the youngest kids

Review some of the top stories from the Contemporary Pediatrics website over the last week, and catch up on anything you may have missed.

In this Contemporary Pediatrics® interview, Rupa Wong, MD, discusses the recent FDA approval of phentolamine ophthalmic solution 0.75% eye drops to treat pharmacologically-induced mydriasis, and how this could impact the treatment landscape for the pediatric population. [Editor's note: RYZUMVI was previously known as Nyxol, which is referenced in the interview.]

Results from the phase 3 MIRA-4 pediatric trial demonstrated a favorable safety and tolerability profile with no reported adverse events. Rupa Wong, MD, offers thoughts on the approval, and why it may not change day-to-day practice when it comes to the pediatric population.

Positive topline results from a pair of identical phase 3 trials support the submission of a supplemental New Drug Application to the FDA for Arcutis Biotherapeutics’ roflumilast cream 0.15%, a once-daily topical to treat mild to moderate atopic dermatitis (AD) in children 6 years or older.

Based on recent positive phase 3 results, Arcutis Biotherapeutics,. intends to submit a supplemental New Drug Application with the FDA for roflumilast cream 0.05% to treat mild to moderate atopic dermatitis in children aged 2 to 5 years.

The FDA issued the Complete Response Letter (CRL) based on the request for a completed pharmacokinetic/pharmacodynamic study to assess how repeat doses of the epinephrine nasal spray compare to repeat doses of an epinephrine injection product. ARS Pharma is set to file a Formal Dispute Resolution Request to appeal the CRL.