Zoryve (roflumilast cream) / Arcutis, Huadong Medicine, Sato Pharma - LARVOL DELTA

INTEGUMENT-INFANT Phase 2 Trial Will Assess Roflumilast in Pediatric Patients with AD (DermatologyTimes) - "The upcoming phase 2, open-label, single-arm INTEGUMENT-INFANT study will assess roflumilast cream 0.05%’s tolerability, safety, and efficacy in patients aged ≥3 months to <2 years...The primary endpoints will include safety and application-site tolerability, assessing changes in vital signs, adverse effects, and serious adverse events. The exploratory endpoints will evaluate effectiveness using the total BSA and Validated Investigator Global Assessment for AD (vIGA-AD) scores, along with the specific levels on the scalp."

Clinical protocol • Atopic Dermatitis

Arcutis Presents Long-Term INTEGUMENT-OLE Data on Roflumilast at RAD 2025 (DermatologyTimes) - P3 | N=1,220 | INTEGUMENT-OLE (NCT04804605) | Sponsor: Arcutis Biotherapeutics, Inc. | "Arcutis Biotherapeutics will be presenting 5 posters at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference in Nashville, Tennessee, including new long-term results of roflumilast (Zoryve) cream 0.05%....At the week 4 mark, 30.2% of patients achieved a validated Investigator Global Assessment (vIGA-AD) score of clear (0) and switched to twice-weekly application. In these participants, the median duration of disease control was 238 days (34 weeks). Disease control was defined as maintaining a vIGA-AD score of clear or almost clear, along with adequate control of signs and symptoms. It was also proven that both roflumilast cream 0.15% and 0.05% significantly improved itch and reduced mean percent body surface area (BSA) in patients 2 and older."

P3 data • Atopic Dermatitis

Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Arcutis Biotherapeutics, Inc.

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and tolerability of roflumilast cream 0.15% for atopic dermatitis: Pooled subgroup analysis of patients with face/eyelid involvement from phase 3 INTEGUMENT-1/2 trials (SID 2025) - P3 | "In the ROF group, no irritation/minimal erythema and no/mild sensation were reported by physicians and patients, respectively, for ≥97% and ≥81% at all timepoints across subgroups. Roflumilast cream 0.15% was well tolerated and improved outcomes in patients with AD involving the face or eyelids."

Clinical • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pain

Revise Phase III protocol: CDSCO Panel Tells Mankind Over Roflumilast Cream (Medical Dialogues) - "Responding to the proposal presented by Mankind Pharmaceutical to manufacture and market selective phosphodiesterase-4 inhibitor Roflumilast Cream 0.3% w/w, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to revise the protocol of the proposed drug in respect to the amount of drugs applied, specific time of application, specific criteria for randomization, specific lab tests to assess the side effects, etc. This came after the firm presented their proposal for the manufacturing and marketing of Roflumilast Cream 0.3% w/w for the indication of topical treatment of plaque psoriasis, including treatment of psoriasis in the intertriginous areas, in patients 6 years of age and older with justification of bioequivalence (BE) waiver and phase III clinical trial protocol."

Clinical protocol • Psoriasis

Roflumilast Cream 0.3% for a Patient With Genital Psoriasis Refractory to Other Topical and Systemic Treatments: A Case Report. (PubMed, J Clin Aesthet Dermatol) - "After 28 weeks of initial treatment with guselkumab, body surface area (BSA) affected had fallen from 42 to 8 percent; however, new genital lesions were noted. At 16 weeks, genital and gluteal cleft disease remained well-controlled with no evidence of active disease. Overall, roflumilast cream 0.3% was well tolerated with no pruritus, folliculitis, irritation, or contact dermatitis observed."

Journal • Contact Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • Psoriasis

Efficacy and Safety of Roflumilast Cream in Atopic Dermatitis: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. (PubMed, Australas J Dermatol) - "This systematic review and meta-analysis evaluated the efficacy and safety of roflumilast cream in treating atopic dermatitis (AD) by analysing data from three randomised controlled trials. The results demonstrated significant improvement in treatment success with roflumilast compared to vehicle creams, with a modest increase in mild adverse events, supporting its potential as an effective and well-tolerated treatment for AD."

Journal • Retrospective data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

Arcutis to Present Two Posters at the 83rd American Academy of Dermatology Annual Meeting (GlobeNewswire) - "Arcutis Biotherapeutics, Inc...today announced that it will present two posters at the 2025 American Academy of Dermatology (AAD) annual meeting which will take place in Orlando, FL, from March 7 – 11, 2025. The Company will present data from two Phase 3 trials (INTEGUMENT-1 and -2) demonstrating pooled safety and local tolerability of roflumilast cream 0.15% in adults and children down to age six with AD who had prior inadequate response, intolerance, and/or contraindications to topical treatments including topical steroids. A second presentation will spotlight data from its Phase 3 ARRECTOR trial demonstrating significant improvements in patient-related outcomes with roflumilast foam 0.3% in individuals older than 12 years with psoriasis of the scalp and body."

P3 data • Atopic Dermatitis • Psoriasis

ZORYVE Cream 0.15% Approved by Health Canada for the Treatment of Mild to Moderate Atopic Dermatitis in Adults and Children as Young as Six Years of Age (Canada Newswire) - "Arcutis Canada...announced today that Health Canada has approved ZORYVE (roflumilast cream 0.15%), for the treatment of mild to moderate atopic dermatitis (AD) in adults and children ages 6 years and older....The approval of ZORYVE cream 0.15% for atopic dermatitis in Canada was supported by positive results from the vehicle-controlled pivotal Phase 3 INTEGUMENT-1 and INTEGUMENT-2 trials..."

Canada approval • Atopic Dermatitis

Pooled Safety and Local Tolerability of Roflumilast Cream 0.15% From the INTEGUMENT-1 and INTEGUMENT-2 Phase 3 Trials of Patients With Atopic Dermatitis: Subgroup Analysis of Patients With Prior Inadequate Response, Intolerance, and/or Contraindications to Topical Treatments (AAD 2025) - P3 | "Roflumilast cream 0.15% was well tolerated in patients with AD, including those with prior TCS, TCI, and/or crisaborole failure. Sponsored by Arcutis Biotherapeutics, Inc."

Clinical • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pain

Arcutis to Highlight Data from Phase 3 Trials for Scalp and Body Psoriasis and Atopic Dermatitis at the 83rd American Academy of Dermatology Meeting (GlobeNewswire) - P3 | N=432 | ARRECTOR (NCT05028582) | Sponsor: Arcutis Biotherapeutics, Inc. | "A second poster presentation shares results from the Phase 3 ARRECTOR trial that outlines improvements in patient-reported outcomes with investigational ZORYVE foam 0.3% compared with vehicle in adults and children aged 12 or older with psoriasis of the scalp and body. ZORYVE foam significantly improved quality of life across the 23-component Scalpdex assessment throughout the eight-week study period. Individuals reported an improvement in symptoms as well as a reduction in how psoriasis impacted their daily life (e.g., embarrassment, stress, affecting clothing choices, or hair styles)."

P3 data • Psoriasis

Arcutis to Highlight Data from Phase 3 Trials for Scalp and Body Psoriasis and Atopic Dermatitis at the 83rd American Academy of Dermatology Meeting (GlobeNewswire) - P3 | N=654 | INTEGUMENT-I (NCT04773587) | P3 | N=683 | INTEGUMENT-II (NCT04773600) | Sponsor: Arcutis Biotherapeutics, Inc. | "The first poster presentation details the positive efficacy, patient reported outcomes, and tolerability for the use of once-daily ZORYVE cream 0.15% in adults and children 6 years and older with mild to moderate AD from the INTEGUMENT 1-2 trials (n=1,337) who reported a prior inadequate response, intolerance or contraindication to topical corticosteroids (TCS; 60.8%), topical calcineurin inhibitors (TCI; 18.1%), or crisaborole (7.3%). At all timepoints assessed during the four-week trial, more than 91% of participants reported no or mild sensation at the application site and investigators reported no irritation or minimal erythema (redness) in ≥ 97% of participants in these subgroups. Improvement in AD was observed across multiple efficacy endpoints and safety was consistent with the overall study population."

P3 data • Atopic Dermatitis

Tapinarof cream (Vtama) for atopic dermatitis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

U.S. FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE (roflumilast) Cream 0.05% for the Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis (GlobeNewswire) - "Arcutis Biotherapeutics...announced the FDA’s acceptance of a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) cream 0.05%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the topical treatment of mild to moderate AD in children 2 to 5 years old. The FDA has set a PDUFA target action date of October 13, 2025 for this application....The sNDA is supported by positive results from the pivotal INTEGUMENT-PED Phase 3 trial (4 weeks), the INTEGUMENT-OLE long-term extension study (up to 52 weeks), as well as a Phase 1 pharmacokinetic study."

FDA filing • PDUFA • Atopic Dermatitis

Arcutis Announces Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "ZORYVE cream: The Company aims to obtain Medicaid coverage in additional states, as well as some Medicare coverage, during 2025....The Company submitted an sNDA for ZORYVE cream 0.05% to the FDA for the treatment of atopic dermatitis in children ages 2 to 5 with an anticipated target action date in Q4 of 2025, if accepted as submitted....ZORYVE foam...which was accepted by the FDA in September with a PDUFA action date set for May 22, 2025....ARQ-255...the Company announced that it completed enrollment in a Phase 1b study evaluating ARQ-255 for the treatment of alopecia areata, with data expected in H1 2025....ARQ-234...being developed as a potential biologic treatment in atopic dermatitis....The Company has continued preclinical development efforts and is working towards submitting an Investigational New Drug application in 2025."

Enrollment closed • IND • P1 data • PDUFA • Reimbursement • Alopecia • Atopic Dermatitis • Psoriasis

Arcutis Announces Publication of Positive Data from INTEGUMENT-PED Trial Evaluating ZORYVE (roflumilast) Cream 0.05% in Children 2 to 5 Years Old with Mild to Moderate Atopic Dermatitis in Pediatric Dermatology (GlobeNewswire) - P3 | N=652 | Integument-PED (NCT04845620) | Sponsor: Arcutis Biotherapeutics, Inc. | "Rapid improvement in itch was observed in children treated with ZORYVE cream within 24 hours of the first application, as measured by the change from baseline in daily WI-NRS scores...35.3% of children treated with ZORYVE cream achieved a four-point reduction in WI-NRS at Week 4 vs. 18.0% for vehicle-treated subjects (nominal P=0.0002). 39.4% of children treated with ZORYVE cream achieved a 75% improvement in EASI score (EASI-75) at Week 4 compared to 20.6% treated with vehicle (P<0.0001). Significant improvements based on EASI-75 were observed with ZORYVE cream compared to vehicle as early as Week 1. 35.4% of children treated with ZORYVE cream 0.05% achieved a vIGA-AD score of ‘clear’ or ‘almost clear’ at Week 4, with significant improvements seen as early as Week 1...We look forward to the FDA’s potential approval of ZORYVE cream 0.05% anticipated later this year."

FDA approval • P3 data • Atopic Dermatitis

Efficacy and Safety of Once-Daily Roflumilast Cream 0.05% in Pediatric Patients Aged 2-5 Years With Mild-to-Moderate Atopic Dermatitis (INTEGUMENT-PED): A Phase 3 Randomized Controlled Trial. (PubMed, Pediatr Dermatol) - P3 | "In this Phase 3 trial, once-daily roflumilast cream 0.05% improved AD signs/symptoms in patients aged 2-5 years, with early pruritus improvement, low AE rates, and local tolerability comparable with vehicle."

Journal • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pediatrics • Pruritus

Pooled Efficacy, Patient-reported Outcomes, and Safety of Roflumilast Cream 0.15% from the INTEGUMENT-1 and INTEGUMENT-2 Phase 3 Trials of Patients with Atopic Dermatitis and Prior Inadequate Response, Intolerance, and/or Contraindications for Topical Corticosteroids (AAAAI-WAO 2025) - P3 | "Investigator- and patient-reported local tolerability were similar between roflumilast and vehicle in both groups. Conclusions Roflumilast cream 0.15% was well tolerated and effective in patients with AD, regardless of prior TCS failure."

Clinical • P3 data • Patient reported outcomes • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Neurodermatitis of the scalp associated with trichotillomania treated with roflumilast cream 0.3. (PubMed, JAAD Case Rep) - No abstract available

Journal • Dermatitis • Dermatology • Immunology

Recalcitrant Pediatric Facial Vitiligo Successfully Treated with Roflumilast Cream 0.3% Once Daily. (PubMed, J Clin Aesthet Dermatol) - "Treatments for pediatric vitiligo in the past has usually included phototherapy, topical corticosteroids, vitamin D and calcineurin inhibitors; topical ruxolitinib has been approved more recently for nonsegmental vitiligo in patients 12 years of age and older. We describe four cases of pediatric skin of color patients with facial vitiligo that were refractory to topical corticosteroids, ruxolitinib and phototherapy. All patients were started on roflumilast cream 0.3% once daily and demonstrated improvement in repigmentation."

Journal • Atopic Dermatitis • CNS Disorders • Depression • Dermatitis • Dermatology • Immunology • Mood Disorders • Pediatrics • Psoriasis • Psychiatry • Seborrheic Dermatitis • Vitiligo

Arcutis Announces Preliminary Unaudited Fourth Quarter Product Revenue and Full-Year 2024 Product Revenues of Approximately $63 Million and $160 Million (GlobeNewswire) - "Preliminary unaudited product revenue for the fourth quarter of 2024 is expected to be approximately $63 million, representing growth of approximately 366% as compared to the fourth quarter of 2023 and approximately 41% as compared to the third quarter of 2024. Preliminary unaudited product revenue for the full-year 2024 is expected to be approximately $160 million, representing growth of approximately 449% vs. 2023; Revenue growth in the fourth quarter across the franchise was driven by strong demand for all ZORYVE (roflumilast) indications, while GTN was similar to the prior quarter."

Commercial • Atopic Dermatitis • Immunology • Psoriasis

Long-Term Safety and Efficacy with Roflumilast Cream 0.15% in Patients Aged ≥6 Years with Atopic Dermatitis: A Phase 3 Open-Label Extension Trial. (PubMed, Dermatitis) - P3 | " Roflumilast cream 0.15% was well tolerated for up to 56 weeks. BIW application to normal-appearing flare-prone sites maintained improvement in AD signs and symptoms, showing that proactive treatment represents an alternative to the current standard practice of reactive treatment."

Journal • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pain

Efficacy and Safety of Roflumilast Cream in Subjects with Atopic Dermatitis (clinicaltrials.gov) - P3 | N=351 | Recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting | N=210 ➔ 351

Enrollment change • Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Arcutis Submits ZORYVE (roflumilast) Cream 0.05% Supplemental New Drug Application to the FDA for the Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis (GlobeNewswire) - "Arcutis Biotherapeutics...announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for ZORYVE (roflumilast) cream 0.05%, a once-daily, next generation phosphodie....The sNDA is supported by positive results from one pivotal Phase 3 trial, one pivotal long-term extension study, as well as a Phase 1 pharmacokinetic study. The INTEGUMENT-PED vehicle-controlled, pivotal Phase 3 trial enrolled 652 children 2 to 5 years of age, with a mean AD Body Surface Area (BSA) of 22% overall, and ranging from 3% to 82%....The submission is also supported by data from the INTEGUMENT-OLE open-label extension study in which patients ages 2 to 5 (n = 562) were treated for up to 52 weeks."

FDA filing • Atopic Dermatitis

HDM3014-301: Efficacy and Safety of Roflumilast Cream 0.3% in Subjects with Plaque Psoriasis: a Phase 3 Study (clinicaltrials.gov) - P3 | N=189 | Recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis