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New Analysis of Organon's VTAMA® (tapinarof) cream, 1%, Phase 3 Data Showed Early and Consistent Improvement in Patient-Reported Sleep Subdomains in Pediatric Patients Down to 2 Years of Age with Atopic Dermatitis

  • Organon will present sub-analysis data from Phase 3 ADORING 1 & 2 trials at the 2026 AAAAI Annual Meeting in Philadelphia on February 27, 2026.
  • VTAMA cream demonstrated clinically meaningful improvements in sleep scores as early as week 1, sustained through week 8.
  • Significant improvements in the Patient-Oriented Eczema Measure (POEM) sleep subdomain were observed in pediatric patients aged 2-17 years with moderate to severe atopic dermatitis.
  • Significant improvements in the Dermatitis Family Impact (DFI) sleep subdomain were observed in family members of patients aged 2-15 years.
  • POEM sleep scores improved significantly by week 1 for children aged 2-6 and 12-17, with improvements for children aged 7-11 observed by week 4.
  • At week 8, mean changes in POEM sleep scores favored VTAMA cream over vehicle across all age groups (2-6, 7-11, 12-17) with statistically significant P-values.
  • DFI sleep scores improved significantly by week 1 for patients aged 12-15, and by week 2 for children aged 2-6 and 7-11.
  • Clinically significant DFI improvements continued through week 8 across pediatric age groups aged 2-15.
  • The most frequently reported treatment-emergent adverse events (≥5%) were folliculitis, headache, and nasopharyngitis.
  • VTAMA cream received FDA approval in December 2024 for topical treatment of atopic dermatitis in adults and pediatric patients aged 2 years and older.
  • VTAMA cream was previously approved by the FDA in May 2022 for topical treatment of plaque psoriasis in adults.
  • The ADORING program included two 8-week pivotal trials (ADORING 1 2) and a 48-week open-label extension trial (ADORING 3).