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Pivotal Safety


ZORYVE is for topical use only and not for ophthalmic, oral, or intravaginal use.1

Well-tolerated in DERMIS-1 and DERMIS-2

  • Not associated with folliculitis1
  • Not associated with atrophy, striae, or HPA-axis suppression1
  • Nearly no stinging and burning* (3 out of 562 patients)2
  • Low rate of discontinuation due to adverse events (1%)1

*Based on patient tolerability assessment from DERMIS clinical trials. At time of first application, 2 of 562 patients (0.4%) treated with ZORYVE vs 0 of 301 patients treated with vehicle experienced hot tingling/stinging sensation. After first application, 1 of 463 patients (0.2%) treated with ZORYVE vs 1 of 250 patients (0.4%) treated with vehicle experienced hot tingling/stinging sensation.2

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.2


No new safety signals were reported and efficacy results were consistent with DERMIS Phase 3 pivotal studies with UP TO 64 WEEKS of treatment10,11†

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.