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Safety

ZORYVE was well-tolerated and safe

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.3

  • Well-tolerated with a very low rate of discontinuation due to adverse events (1%)1
  • Favorable local tolerability with a very low rate of application site pain (1%)1

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 treatment*3

*A Phase 2, 52-week open-label, long-term safety study of roflumilast cream 0.3% was conducted with a treatment-naïve cohort and a cohort continuing from the Phase 2b study, regardless of treatment response. For patients that clear, treatment could be stopped and resumed if psoriasis returned. Eligible patients (n=230) who completed the Phase 2b study (roflumilast cream 0.15%, 0.3%, or vehicle) 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.

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