The Food and Drug Administration (FDA) has approved Dificid (fidaxomicin) for the treatment of Clostridioides difficile-associated diarrhea in adult and pediatric patients aged 6 months and older. Previously, the treatment had only been approved for adults ≥18 years of age. Additionally, an oral suspension formulation of fidaxomicin, a macrolide antibacterial, has also been approved.
The pediatric approval was based on data from the phase 3 SUNSHINE study, which evaluated the clinical response of fidaxomicin vs vancomycin in pediatric patients with C difficile-associated diarrhea (N=148). The primary end point of the study was clinical response defined in patients <2 years old as the absence of watery stools for at least 2 consecutive days while on treatment with no requirement for further therapy through 2 days after completing treatment. In patients ≥2 to <18 years, clinical response was defined as <3 unformed bowel movements for at least 2 consecutive days while on treatment and no requirement for further therapy through 2 days after completing treatment.
Results from the trial showed clinical response in the overall pediatric population was similar between the fidaxomicin and vancomycin groups (77.6% vs 70.5%; treatment difference: 7.5 [95% CI, -7.4 to 23.9]). Moreover, sustained clinical response, a secondary end point defined as the proportion of treated patients with confirmed clinical response and no C difficile-associated diarrhea recurrence through 30 days after the end of treatment, was higher for fidaxomicin than for vancomycin (68.4% vs 50.0%; treatment difference: 18.4 [95% CI, 1.5 to 35.3]).
As for safety, the most common adverse reactions in pediatric patients treated with fidaxomicin were pyrexia, abdominal pain, vomiting, diarrhea, constipation, increased aminotransferases and rash.
Dificid is currently available as a 200mg tablet. The oral suspension will be supplied as granules in bottles containing 5.45g of fidaxomicin (40mg of fidaxomicin per mL after reconstitution).
For more information visit merck.com.
This article originally appeared on MPR