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ZORYVE Cream ZORYVE Foam

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ZORYVE® (roflumilast) is a once-daily and steroid-free prescription topical

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ZORYVE (roflumilast) cream 0.15%, ZORYVE (roflumilast) foam 0.3% and ZORYVE (roflumilast) cream 0.3%

ZORYVE (roflumilast) cream 0.15%, ZORYVE (roflumilast) foam 0.3% and ZORYVE (roflumilast) cream 0.3%

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IMPORTANT SAFETY INFORMATION

ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application.

The most common adverse reactions (≥1%) for ZORYVE cream 0.15% for atopic dermatitis include headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).

The most common adverse reactions (≥1%) for ZORYVE cream 0.3% for plaque psoriasis include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).

INDICATIONS

ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older.

ZORYVE foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.

ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older.

Please see full Prescribing Information for ZORYVE cream and full Prescribing Information for ZORYVE foam.

Pivotal Study Designs

Atopic Dermatitis: Two Phase 3 multicenter, randomized, double-blind, vehicle-controlled studies (INTEGUMENT 1 & 2) evaluated 1337 participants with mild to moderate atopic dermatitis treated with ZORYVE or vehicle once daily for 4 weeks. ZORYVE cream = 884, vehicle = 453. Primary endpoint was vIGA-AD Success at Week 4. WI-NRS Success at Week 4 was a key secondary endpoint.¹

Seborrheic Dermatitis: Two multicenter, randomized, double-blind, vehicle-controlled studies (STRATUM and Trial 203) evaluated 683 participants with moderate to severe seborrheic dermatitis treated with ZORYVE or vehicle once daily for 8 weeks. STRATUM: ZORYVE foam = 304, vehicle = 153. Trial 203: ZORYVE foam = 154, vehicle = 72. Primary endpoint was IGA Success at Week 8.²

Plaque Psoriasis: Two Phase 3 randomized, parallel, double-blind, vehicle-controlled, multicenter studies (DERMIS-1 and DERMIS-2) evaluated 881 participants with plaque psoriasis treated with ZORYVE or vehicle once daily for 8 weeks. ZORYVE = 576, vehicle = 305. Primary endpoint was IGA Success at Week 8.¹

IGA Success/vIGA-AD Success = Achievement of Clear/Almost Clear and a ≥2-grade improvement from baseline.

IGA = Investigator Global Assessment.

vIGA-AD = Validated Investigator Global Assessment—Atopic Dermatitis.

WI-NRS Success defined as a ≥4-point improvement for patients with a baseline score ≥4. WI-NRS:0 (no itch) to 10 (worst imaginable itch).

WI-NRS = Worst Itch Numeric Rating Scale.

References: 1. ZORYVE^® cream. Prescribing information. Arcutis Biotherapeutics, Inc; 2024. 2. ZORYVE^® foam. Prescribing information. Arcutis Biotherapeutics, Inc; 2023. 3. Stein Gold L, Bagel J, Del Rosso J, et al. Pooled efficacy and safety results from the DERMIS-1 and DERMIS-2 Phase 3 trials of once-daily roflumilast cream 0.3% by baseline body surface area. Poster presented at: American Academy of Dermatology Annual Meeting; March 25-29, 2022; Boston, MA. 4. Ferris LK, Armstrong A, Del Rosso J, et al. Efficacy and tolerability of roflumilast cream 0.3% in patients with chronic plaque psoriasis involvement on the face, intertriginous, or genital areas: Pooled results from Phase 3 trials (DERMIS-1 and DERMIS-2). Poster presented at: European Academy of Dermatology and Venereology Congress; September 7-11, 2022; Milan, Italy. 5. Bunick CG, Bhatia N, Del Rosso J, et al. Investigator and patient-rated local tolerability in Phase 3 trials of topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis. Poster presented at: Fall Clinical Dermatology Conference; October 19-22, 2023; Las Vegas, NV. 6. Lebwohl M, Stein Gold L, Gooderham MJ, et al. Durability of efficacy and safety of roflumilast cream 0.3% in adults with chronic plaque psoriasis from a 52-week, Phase 2 open-label safety trial. Poster presented at: Winter Clinical Dermatology Conference; January 13-18, 2023; Kohala Coast, HI. 7. Alexis AF, Zirwas M, Bukhalo M, et al. Long-term safety and efficacy of roflumilast foam 0.3% in patients with seborrheic dermatitis in a 24–52-week, open-label Phase 2 trial. Poster presented at: The European Academy of Dermatology and Venereology Congress; September 7-11, 2022; Milan, Italy. 8. Simpson EL, Eichenfield LF, Papp KA, et al. Long-term safety and efficacy of roflumilast cream 0.15% in adults and children aged ≥6 years with mild to moderate atopic dermatitis: A 52-week, Phase 3, open-label safety trial. Poster presented at: Revolutionizing Alopecia Areata, Vitiligo, and Eczema (RAVE) Conference; June 8-10, 2024; Chicago, IL. 9. Data on File. Arcutis Biotherapeutics, Inc. 10. Simpson E, Boguniewicz M, Eichenfield L, et al. Pooled efficacy, patient-reported outcomes, and safety of roflumilast cream 0.15% from the INTEGUMENT-1 and INTEGUMENT-2 Phase 3 clinical trials of adults and children with atopic dermatitis. Poster presented at: American Academy of Dermatology Annual Meeting; March 8-12, 2024; San Diego, CA. 11. Lebwohl M, Gooderham MJ, Guenthner ST, et al. Pooled efficacy and safety results from the DERMIS-1 and DERMIS-2 Phase 3 trials of once-daily roflumilast cream 0.3% for the treatment of plaque psoriasis. Poster presented at: American Academy of Dermatology Annual Meeting; March 25-29, 2022; Boston, MA. 12. Osborne DW, Musakhanian J. Skin penetration and permeation properties of Transcutol^®- neat or diluted mixtures. AAPS PharmSciTech. 2018;19(8):3512-3533. 13. Osborne DW. Diethylene glycol monoethyl ether: an emerging solvent in topical dermatology products. J Cosmet Dermatol. 2011;10:325-329. 14. Berk D, Osborne DW. Krafft temperature of surfactants in vehicles for roflumilast and pimecrolimus cream and effects on skin tolerability. Poster presented at: The Society for Investigative Dermatology Annual Meeting; May 18-22, 2022; Portland, OR. 15. Björklund S, Pham QD, Jensen LB, et al. The effects of polar excipients transcutol and dexpanthenol on molecular mobility, permeability, and electrical impedance of the skin barrier. J Colloid Interface Sci. 2016;479:207-220. 16. CMS.gov. 2024 ICD-10-CM. Centers for Medicare & Medicaid Services. Updated February 1, 2024. Accessed April 20, 2024. https://www.cms.gov/medicare/coding-billing/icd-10-codes/2024-icd-10-cm 17. Sidbury R, Alikhan A, Bercovitch L, et al. Guidelines of care for the management of atopic dermatitis in adults with topical therapies. J Am Acad Dermatol. 2023; 89(1):e1-e20. 18. Clark GW, Pope SM, Jaboori KA. Diagnosis and treatment of seborrheic dermatitis. Am Fam Physician. 2015;91(3):185-190. 19. Elmets CA, Korman NJ, Prater EF, et al. Joint AAD-NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol. 2021;84(2):432-470.

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IMPORTANT SAFETY INFORMATION
AND INDICATIONS

IMPORTANT SAFETY INFORMATION

ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application.

The most common adverse reactions (≥1%) for ZORYVE cream 0.15% for atopic dermatitis include headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).

The most common adverse reactions (≥1%) for ZORYVE cream 0.3% for plaque psoriasis include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).

INDICATIONS

ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older.

ZORYVE foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.

ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older.

Please see full Prescribing Information for ZORYVE cream and full Prescribing Information for ZORYVE foam.

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