Background glowHand with a small amount of ZORYVE cream on fingertip

Actor portrayal

Background glowHand with a small amount of ZORYVE cream on fingertip

Actor portrayal

 Pivotal Safety

CONSISTENTLY WELL TOLERATED AND SAFE

SAFE FOR ANY LOCATION

IN DERMIS-1 AND DERMIS-2:

  • Low rates of stinging or burning (0.4%)5*
  • Not associated with folliculitis1
  • Not associated with atrophy, striae, or HPA-axis suppression1
  • Low rate of discontinuation due to adverse events (1%)1

*Low rates of hot tingling/stinging sensation reported in patient-rated tolerability assessments 10–15 minutes after first application: 0.4% with ZORYVE (n=562) vs 0.0% with vehicle (n=301).

Adverse reactions reported in ≥1% of patients treated with ZORYVE for 8 weeks in DERMIS-1 and DERMIS-21

ZORYVE(N=576)Vehicle(N=305)DiarrheaHeadacheInsomniaNauseaUpper respiratory tract infectionApplication site painUrinary tract infection18 (3.1%)0 (0.0%)14 (2.4%)3 (1.0%)8 (1.4%)2 (0.7%)7 (1.2%)1 (0.3%)6 (1.0%)6 (1.0%)1 (0.3%)1 (0.3%)6 (1.0%)2 (0.7%)
ZORYVE(N=576)Vehicle(N=305)DiarrheaHeadacheInsomniaNauseaApplication site painUpper respiratorytract infectionUrinary tract infection18 (3.1%)14 (2.4%)8 (1.4%)7 (1.2%)6 (1.0%)6 (1.0%)6 (1.0%)0 (0.0%)3 (1.0%)2 (0.7%)1 (0.3%)1 (0.3%)1 (0.3%)2 (0.7%)

17 of 18 patients experienced mild diarrhea. Most patients reported cases in the first 2 weeks and resolved with continued dosing. No patients discontinued or interrupted treatment due to diarrhea.7

PHASE 2 LONG-TERM SAFETY STUDY

No new safety signals were reported, and efficacy results were consistent with DERMIS Phase 3 pivotal studies with UP TO 64 WEEKS of treatment6†

SEE LONG-TERM SAFETY DATA

†A Phase 2, 52-week open-label, long-term safety study of roflumilast cream 0.3% was conducted with a treatment-naïve cohort (Cohort 2) and a cohort continuing from the Phase 2b study (Cohort 1), regardless of treatment response. For patients that clear, treatment could be stopped and resumed if psoriasis recurred. Eligible patients (n=230) who completed the Phase 2b study [roflumilast cream 0.15% (n=83), 0.3% (n=81), or vehicle (n=66)] through Week 12 were enrolled, with 81 patients receiving roflumilast cream 0.3% for a total of up to 64 weeks of treatment. Efficacy measures were included as secondary endpoints and the statistics concluded are descriptive. These data are not included in the Prescribing Information for ZORYVE.

HPA = Hypothalamic-Pituitary-Adrenal.

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