For U.S. Healthcare Professionals Only
Prescribing information for Cream, Foam
ZORYVE® IT
RELIEVE IT

The power and versatility to be your go-to topical1

ZORYVE® (roflumilast)
Now
Available
THE POWERFUL
FOAM YOU’VE BEEN
WAITING FOR
Foam 0.3%
For age 12+
Delivers powerful skin clearance and rapid itch relief, from head to toe1
Well tolerated and safe for any skin and hair type1,2
Simple, once-daily treatment1
Not a steroid1

POWERFUL SKIN CLEARANCE ANYWHERE DISEASE PRESENTS1,3

ZORYVE is for topical use only and not for ophthalmic, oral, or intravaginal use.1
SCALP*
63%
of patients achieved S-IGA Success at Week 8 using ZORYVE foam 0.3% (n=481) vs 21% with vehicle (n=255)
P<0.0001 vs vehicle, nominal.
BODY*
42%
of patients achieved B-IGA Success at Week 8 using ZORYVE foam 0.3% (n=481) vs 15% with vehicle (n=255)
P<0.0001 vs vehicle, nominal.
*
Data are pooled analyses of the ARRECTOR and Trial 204 studies.
Measured by S-IGA Success=Achievement of an S-IGA score of Clear (0) or Almost Clear (1) plus a ≥2-grade improvement from baseline.
Measured by B-IGA Success=Achievement of a B-IGA score of Clear (0) or Almost Clear (1) plus a ≥2-grade improvement from baseline.
Pivotal Study Design

Two multicenter, randomized, parallel, double-blind, vehicle-controlled studies (ARRECTOR and Trial 204) evaluated 736 participants with plaque psoriasis treated with ZORYVE foam 0.3% or vehicle once daily for 8 weeks. ZORYVE = 481, vehicle = 255.

Primary endpoints were S-IGA Success at Week 8 in both studies, and B-IGA Success at Week 8 in ARRECTOR. Key secondary endpoints were B-IGA Success at Week 8 in Trial 204, SI-NRS Success at Week 8 in ARRECTOR: ZORYVE foam = 203, vehicle = 123, and WI-NRS Success at Week 8 in ARRECTOR: ZORYVE foam = 203, vehicle = 110.1,4,5

RAPID ITCH RELIEF FROM HEAD TO TOE1,4
In ARRECTOR
SCALP§
Line graph showing SI-NRS success over 8 weeks. ZORYVE foam 0.3% outperforms Vehicle, with 65% of patients achieving success by Week 8 vs. 30% for Vehicle.
P<0.001 vs vehicle at all time points.
BODYII
Line graph showing WI-NRS success over 8 weeks. ZORYVE foam 0.3% leads to higher success (63% at Week 8) compared to Vehicle (30%).
P<0.001 vs vehicle at all time points, nominal at Weeks 2 and 4.
Greater itch improvement experienced within 24 hours
after first application across the scalp and body with ZORYVE vs. vehicle (both SI-NRS and WI-NRS; P<0.05)4⁋#
§
Measured by SI-NRS Success=Achievement of ≥4-point improvement from baseline in patients with baseline SI-NRS ≥4. SI-NRS: 0 (no itch) to 10 (worst imaginable itch).
||
Measured by WI-NRS Success=Achievement of ≥4-point improvement from baseline in patients with baseline WI-NRS ≥4. WI-NRS: 0 (no itch) to 10 (worst imaginable itch).​
Data from ARRECTOR study only.​
#
Measured by change from first application in daily SI-NRS/WI-NRS. P-value for WI-NRS is nominal.
RELIABLE RESULTS PATIENTS CAN SEE AND FEEL3
SCALP
Age 56, Male
Image of scalp at baseline
BASELINE S-IGA=4
Image of scalp at week 8
WEEK 8 S-IGA=1
TRUNK
Age 59, Female
Image of trunk at baseline
BASELINE B-IGA=3
Image of trunk at week 8
WEEK 8 B-IGA=0
LEG
Age 56, Male
Image of leg at baseline
BASELINE B-IGA=2
Image of leg at week 8
WEEK 8 B-IGA=1
Actual clinical trial patients.
WELL TOLERATED AND SAFE FOR ANY DURATION OR BODY LOCATION1
Adverse reactions reported in ≥1% of patients treated with ZORYVE for 8 weeks
ARRECTOR
and Trial 204
ZORYVE foam (N=479)
Vehicle (N=255)
Headache
3.1%
1.2%
Diarrhea
2.5%
1.6%
Nausea
1.7%
0.0%
Nasopharyngitis
1.3%
0.8%
Low rates of stinging or burning (0.4%)6**
Not associated with folliculitis, atrophy, striae or HPA-axis suppression1
Low rate of discontinuation due to adverse events (2.1%)3
**
Low rates of hot, tingling/stinging sensation reported in patient-rated tolerability assessments 10–15 minutes after first application: In ARRECTOR 0.4% for ZORYVE foam (n=280) vs 1.4% for vehicle (n=148).6
ZORYVE foam is designed with purpose and the patient in mind
Simple foam application anywhere on the body, including difficult-to-treat scalp and other hair-bearing areas.
Formulated for all skin & hair types1
Spreads easily, absorbs quickly, non-greasy.
Moisturizing properties1,7-9
Novel, water-based emollient formulation.
No known sensitizers or irritants1
No fragrances or alcohols.
Drug delivery without disrupting the skin barrier1,7,9,10
No penetration enhancers or ceramide-stripping properties.
GIVE YOUR PATIENTS WITH PLAQUE PSORIASIS THE POWER OF CHOICE1,11
The first and only FDA-approved branded topical in foam and cream options to treat anywhere disease presents — from head to toe1,3,11
ZORYVE cream for plaque psoriasis
Discover ZORYVE CREAM 0.3% for plaque psoriasis
ZORYVE Direct savings card
Get the ZORYVE Direct Savings Card
ZORYVE is for topical use only and not for ophthalmic, oral, or intravaginal use.1,11