Shorter antibiotic course shown safe, effective for uncomplicated childhood CAP
A 5-day antibiotic strategy in children with community-acquired pneumonia (CAP) resulted in similar treatment response with fewer antibiotic days compared with a 10-day strategy, according to a study published online January 18, 2022, in JAMA Pediatrics.
The randomized, double-blind, placebo-controlled clinical trial conducted in outpatient clinic, urgent care, or emergency settings in eight US cities involved 380 healthy children (189 given short-course and 191 given standard-course antibiotics), 6 to 71 months of age, with nonsevere CAP demonstrating early clinical improvement. On Day 6 of their originally prescribed therapy, study participants were randomized 1:1 to receive 5 days of matching placebo or 5 additional days of the same antibiotic.
The 5-day strategy was associated with a 69% probability of a more desirable outcome compared with standard-course strategy and a significantly lower abundance of antibiotic resistance genes. The researchers concluded that the shorter-course antibiotic regimen was superior to a 10-day strategy for outpatient treatment of nonsevere pneumonia in those responding to initial treatment. The shortened approach resulted in similar clinical response and antibiotic-associated adverse reactions while reducing antibiotic exposure and resistance.
FDA approves new nasal spray for seasonal allergic rhinitis
The FDA approved Ryaltris (olopatadine hydrochloride/mometasone furoate) nasal spray-a combination histamine1 receptor inhibitor/corticosteroid-for the treatment of symptoms associated with seasonal allergic rhinitis in adults and pediatric patients 12 years of age and older. Ryaltris is a metered, fixed-dose, aqueous suspension, prescription nasal spray. Each unit of Ryaltris nasal spray contains 665 mcg of olopatadine hydrochloride and 25 mcg of mometasone furoate.
The safety and effectiveness of Ryaltris in pediatric patients younger than 12 years of age has not been established. The recommended daily dose of Ryaltris is two sprays in each nostril twice daily. In clinical trials, Ryaltris was associated with statistically significant improvement in average morning and evening patient-reported 12-hour nasal symptom scores and reflective total ocular symptom scores compared with placebo. The most common adverse reactions reported with Ryaltris were dysgeusia, epistaxis, and nasal discomfort.
Ryaltris is a product of Glenmark Pharmaceuticals.
New drug approved for insomnia in adults
The FDA approved Quviviq (daridorexant) 25 mg and 50 mg for the treatment of adults with insomnia characterized by difficulties with sleep onset and/or maintenance. Unlike treatments that are sedating, Quviviq blocks the binding of wake-promoting neuropeptides and is thought to reduce overactive wakefulness.
Quviviq's FDA approval was based on data from clinical trials across 18 countries. Quviviq was shown to be associated with significant improvement versus placebo on objective measures of sleep onset and sleep maintenance and patient-reported total sleep time. The 50 mg dose of Quviviq demonstrated a significant reduction in patient-reported daytime sleepiness. The most common adverse reactions reported in clinical trials were headache and somnolence or fatigue.
Quviviq is a product of Idorsia Pharmaceuticals.