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

Roflumilast for the Treatment of Seborrheic Dermatitis: A Review. (PubMed, Skin Therapy Lett) - "Recent clinical trials have validated the efficacy of non-steroidal roflumilast 0.3% foam for the treatment of SD. In this review, we analyze the safety and efficacy profile of roflumilast 0.3% foam."

Journal • Review • Dermatitis • Dermatology • Immunology • Inflammation • Seborrheic Dermatitis

Roflumilast Foam 0.3% in Patients With Scalp and Body Psoriasis: Improvements in Patient-Reported Outcomes (AAD 2025) - P3 | "Treatment with roflumilast foam 0.3% improved patient-reported outcomes and quality of life in patients with scalp and body psoriasis. Sponsored by Arcutis Biotherapeutics, Inc."

Clinical • Patient reported outcomes • Dermatology • Immunology • Pruritus • Psoriasis

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

Child and Adult Seborrheic Dermatitis: A Narrative Review of the Current Treatment Landscape. (PubMed, Dermatol Ther (Heidelb)) - "The treatment of SD requires an individualized approach, utilizing a range of topical, systemic, and procedural interventions. The advent of new treatments like roflumilast foam offers novel, well-tolerated, and safer options than what has been available in the past."

Journal • Review • Dermatitis • Dermatology • Immunology • Seborrheic Dermatitis

Real-World Use of Tapinarof Cream 1% Once Daily in Patients with Seborrheic Dermatitis: A Case Series. (PubMed, J Clin Aesthet Dermatol) - "Topical roflumilast foam was approved for the treatment of SD in 2023, but additional options are needed. The efficacy and potential remittive effect may be attributed to the unique mechanism of action and clinical profile of tapinarof cream. Tapinarof is a novel topical therapy that may be beneficial for patients with SD."

Journal • Real-world evidence • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Psoriasis • Seborrheic Dermatitis

Arcutis Canada Announces Health Canada Approval of ZORYVE Foam to Treat Seborrheic Dermatitis in Individuals 9 Years of Age and Older (Canada Newswire) - "Arcutis Canada Inc...is pleased to announce that Health Canada has approved ZORYVE (roflumilast foam 0.3%), for the treatment of seborrheic dermatitis in patients 9 years of age and older. Health Canada's approval of this steroid-free, once-daily phosphodiesterase-4 (PDE4) inhibitor brings a novel approach to the management of seborrheic dermatitis, offering a new once-daily treatment option for this chronic skin condition....Health Canada approval of ZORYVE foam is based on Phase 2 and pivotal Phase 3 trial results."

Canada approval • Immunology • Seborrheic Dermatitis

Arcutis Announces Health Canada Approval of ZORYVE (Roflumilast) Foam 0.3% to Treat Seborrheic Dermatitis in Individuals 9 Years of Age and Older (GlobeNewswire) - "Arcutis Biotherapeutics, Inc...announced that its wholly-owned subsidiary Arcutis Canada, Inc. has received regulatory approval from Health Canada for ZORYVE (roflumilast) topical foam 0.3% for the treatment of seborrheic dermatitis in patients 9 years of age and older....The approval of ZORYVE foam 0.3% for seborrheic dermatitis in Canada was supported by positive results from a vehicle-controlled pivotal Phase 3 study (STRATUM), as well as a Phase 2 study, a long-term open-label extension study, and a Phase 1 pharmacokinetic study."

Canada approval • Dermatitis • Immunology • Seborrheic Dermatitis

Recalcitrant Folliculitis Decalvans Successfully Treated with Roflumilast 0.3% (EADV 2024) - "Roflumilast is more potent than apremilast and crisaborole, with roflumilast more closely mimicking the three key binding sites of cAMP to PDE4...The patient was subsequently treated with ketoconazole shampoo, clindamycin solution, clobetasol shampoo and multiple courses of week-long oral antibiotics with only temporary and partial relief...For ease of application, the patient will continue on roflumilast foam 0.3% once daily and start isotretinoin 10mg every third day... This case report of a 35-year-old male with folliculitis decalvans recalcitrant to topical antifungals, topical corticosteroids and oral antibiotics was successfully treated with roflumilast cream 0.3% resulting in a reduction of erythematous papules with improvement in tenderness and pruritus. These results suggest that roflumilast cream 0.3% may be a suitable treatment option for patients with folliculitis decalvans when other treatments offer limited support. Early, safe treatments are essential for..."

Alopecia • Cardiovascular • Dermatitis • Dermatology • Dermatopathology • Heart Failure • Inflammation • Pain • Pruritus • Psoriasis • Seborrheic Dermatitis

FDA Accepts Arcutis’ Supplemental New Drug Application for ZORYVE (roflumilast) Foam for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over (GlobeNewswire) - "Arcutis Biotherapeutics, Inc...announced the FDA has accepted its sNDA for ZORYVE (roflumilast) foam 0.3%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis. The FDA assigned the application a PDUFA target action date of May 22, 2025....The sNDA is supported by positive results from Arcutis’ pivotal ARRECTOR Phase 3 trial..."

FDA filing • PDUFA • Dermatology • Immunology • Psoriasis

Arcutis Announces Second Quarter 2024 Financial Results and Provides Business Update (Yahoo Finance) - "Second quarter net product revenues for ZORYVE franchise of $30.9M, with $17.3M for ZORYVE (roflumilast) cream 0.3%, and $13.6M for ZORYVE (roflumilast) topical foam, 0.3%; sales growth of 547% vs. Q2 '23 and 43% vs. Q1 '24...U.S. Demand for ZORYVE cream in plaque psoriasis continues to grow, with over 252,000 prescriptions filled to date since launch by close to 13,000 unique prescribers, reflecting the high levels of patient and physician satisfaction with the ZORYVE cream clinical profile."

Commercial • Sales • Dermatology • Immunology • Psoriasis • Seborrheic Dermatitis

Biologic and Small-Molecule Treatments in Scalp and Nail Psoriasis (INDERCOS 2024) - "6 Roflumilast foam 0.3% was evaluated in a phase II trial in patients with scalp and body psoriasis...A total of 68 studies on 15 nail psoriasis targeted therapeutic agents which are TNF-alpha inhibitors (adalimumab, infliximab, etanercept, certolizumab, golimumab), IL-17 inhibitors (ixekizumab, brodalumab, secukinumab), IL-12/23 inhibitors (ustekinumab), IL-23 inhibitors (guselkumab, risankizumab, tildrakizumab), PDE-4 inhibitors (apremilast), and JAK inhibitors (tofacitinib)...9 The therapy choices in NP have increased with the approval of new biologics and small molecules such as brodalumab, risankizumab, tildrakizumab, bimekizumab, and deucravacitinib...However, most RCTs assessing SP and NP outcomes are subgroup or post-hoc analyses of patients with scalp and nail involvement among larger PsO/PsA populations. RCTs particularly focusing on SP and NP are needed for better evaluation of efficacy and safety results of biologic and small molecule inhibitors."

Dermatology • Immunology • Inflammatory Arthritis • Pruritus • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL17A • IL23A • TYK2

Arcutis Announces ZORYVE U.S. Co-promote Agreement with Kowa Pharmaceuticals America, Inc. (GlobeNewswire) - "Arcutis Biotherapeutics, Inc...today announced the signing of a co-promotion agreement with Kowa Pharmaceuticals America, Inc., a company committed to the development and commercialization of safe and effective healthcare solutions. Under the agreement, Kowa will leverage its primary care sales force to market and promote ZORYVE (roflumilast) cream and ZORYVE (roflumilast) foam to primary care practitioners and pediatric....Arcutis will recognize all revenue and will have sole responsibility for the manufacturing of ZORYVE during the 5-year term of the partnership....kowa will promote ZORYVE in priority position throughout the term of the partnership, and receive a commission on their sales. Financial terms of the agreement were not disclosed."

Licensing / partnership • Atopic Dermatitis • Immunology • Psoriasis • Seborrheic Dermatitis

Arcutis Submits Supplemental New Drug Application for ZORYVE (roflumilast) Foam to the FDA for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over (GlobeNewswire) - "Arcutis Biotherapeutics, Inc...announced the submission of a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) foam 0.3%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis."

FDA filing • Immunology • Psoriasis

Expert Panel Review Further Validates Use of ZORYVE (roflumilast) Topical Foam, 0.3% for Treatment of Seborrheic Dermatitis Across Diverse Hair Types Published in Journal of Clinical and Aesthetic Dermatology (GlobeNewswire) - "Arcutis Biotherapeutics, Inc...today announced that the Journal of Clinical and Aesthetic Dermatology (JCAD) published the outcomes of a comprehensive evaluation by an expert dermatologist panel assessing the formulation ingredients of ZORYVE (roflumilast) topical foam, 0.3%. ZORYVE foam is a once-daily steroid-free treatment for seborrheic dermatitis. The published article supports the use of ZORYVE foam in all hair and skin types....Consultation with an expert dermatologist panel composed of leading medical and cosmetic dermatologists with expertise in formulation from medical centers, dermatology clinics, and academic institutions across the United States confirms that the formulation of ZORYVE foam excludes harmful ingredients including thickening agents, alcohol, fragrances, essential oils, and oxidizing agents."

Clinical • Immunology • Seborrheic Dermatitis

Putting the Formulation Back in Foam: Optimizing Seborrheic Dermatitis Treatment Across Diverse Hair Types. (PubMed, J Clin Aesthet Dermatol) - "A novel roflumilast foam formulation has emerged as a promising therapeutic option optimally designed for use on the scalp and other hair-bearing areas. We conducted a comprehensive assessment of beauty industry standards, confirming the foam formulation's alignment with industry guidelines and exclusion of potentially harmful ingredients. In addition, consultation with an expert dermatologist panel yielded a strong endorsement, underscoring a high level of confidence in prescribing the foam across diverse hair and skin types."

Journal • Dermatitis • Dermatology • Immunology • Seborrheic Dermatitis

Arcutis Announces First Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Roflumilast foam...Based on the positive topline results from the ARRECTOR pivotal Phase 3 trial for the treatment of scalp and body psoriasis, the Company anticipates submitting an sNDA for scalp and body psoriasis to the FDA in the third quarter of 2024....Revenues for the quarter were $15.0 million for ZORYVE (roflumilast) cream 0.3% and $6.5 million for ZORYVE (roflumilast) topical foam, 0.3%. Year-over-year increases were due to strong unit demand as well as improvements in GTN sales deductions."

Sales • sNDA • Immunology • Psoriasis

When Patient Diversity Informs Formulation: Reimagining Treatment for Seborrheic Dermatitis. (PubMed, Dermatol Ther (Heidelb)) - "Newly US Food and Drug Administration (FDA)-approved roflumilast 0.3% foam presents a significant advancement in the treatment of SD owing to its pH-balanced, residue-free formulation that is suited for all hair types, including patients with curly or coiled hair. It presents a culturally inclusive treatment option that offers effective management of SD while maintaining hair health and respecting diverse hair care needs and practices."

Journal • Dermatitis • Dermatology • Immunology • Seborrheic Dermatitis

Anti-fungal effects on Malassezia species in an open-label, phase 1, maximal use study of roflumilast foam 0.3% in patients with seborrheic dermatitis (SID 2024) - No abstract available

Clinical • P1 data • Dermatitis • Dermatology • Immunology • Seborrheic Dermatitis

Roflumilast foam (Zoryve) for seborrheic dermatitis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dermatitis • Dermatology • Immunology • Seborrheic Dermatitis

Impact of roflumilast foam 0.3% on patient- reported quality of life in seborrheic dermatitis: An analysis of STRATUM data for patients unresponsive or intolerant to topical corticosteroids (AMCP 2024) - "These results suggest that roflumilast foam 0.3% provides significant and meaningful quality-of-life benefits for patients with moderate to severe SD with an in- adequate response, intolerance, or contraindication to TCS."

Clinical • HEOR • Dermatitis • Dermatology • Immunology • Seborrheic Dermatitis

Effect of roflumilast foam 0.3% on quality of life in patients with seborrheic dermatitis: Patient- reported outcomes from the STRATUM phase 3 trial (AMCP 2024) - "As early as week 2, treatment with roflu- milast demonstrated a significantly larger reduction (improvement) in DLQI scores compared with vehicle, with improvements maintained through week 8. Relative to vehicle, the roflumilast group had a higher likelihood of achieving meaningful improvement in QOL and reduction of DLQI scores to levels that reflect no patient impact. The results suggest that roflumilast foam 0.3% has a meaningful impact on the QOL burden associated with SD."

Clinical • HEOR • P3 data • Dermatitis • Dermatology • Immunology • Seborrheic Dermatitis

Roflumilast foam 0.3% once daily in patients with seborrheic dermatitis: Improvement in patient reported outcomes and pruritus from a phase 3 trial (STRATUM) (AAD 2024) - P3 | "Roflumilast cream 0.3% is approved as a once-daily, nonsteroidal cream for patients with chronic plaque psoriasis, including sensitive areas such as intertriginous, face, and genital areas. Treatment with once-daily roflumilast foam 0.3% reduced pruritus and improved quality of life with favorable tolerability. Sponsored by Arcutis Biotherapeutics, Inc."

Clinical • P3 data • Patient reported outcomes • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • Psoriasis • Seborrheic Dermatitis

Patient-reported outcomes with roflumilast foam 0.3% in patients with scalp and body psoriasis in the phase 3 ARRECTOR trial (AAD 2024) - P3 | "Roflumilast foam 0.3% improved quality of life associated with scalp and body psoriasis itching, pain, and scaling. Sponsored by Arcutis Biotherapeutics, Inc."

Clinical • P3 data • Patient reported outcomes • Dermatology • Immunology • Pain • Pruritus • Psoriasis

Arcutis and Sato Announce Strategic Collaboration and Licensing Agreement for Topical Roflumilast in Japan (GlobeNewswire) - "Arcutis Biotherapeutics, Inc...and Sato Pharmaceutical Co., Ltd...today announced that the companies have entered into a strategic collaboration and licensing agreement for the development, manufacture, and commercialization of topical roflumilast in Japan. Sato will receive an exclusive license for both the cream and foam formulations of topical roflumilast...for multiple dermatological conditions including plaque psoriasis, seborrheic dermatitis, atopic dermatitis, and potentially additional dermatological conditions in the future....Sato will be responsible for development, manufacturing, and commercialization of roflumilast cream and roflumilast foam and other topical roflumilast presentations in Japan."

Licensing / partnership • Atopic Dermatitis • Dermatitis • Immunology • Psoriasis • Seborrheic Dermatitis

Roflumilast foam 0.3% for adolescent and adult patients with seborrheic dermatitis: A randomized, double-blinded, vehicle-controlled, phase 3 trial. (PubMed, J Am Acad Dermatol) - "Once-daily roflumilast foam was superior to vehicle in leading to IGA of Clear or Almost Clear plus ≥2-point improvement from baseline at 8 weeks in patients with SD. Longer trials are needed to determine durability and safety of roflumilast foam in SD."

Clinical • Journal • P3 data • Dermatitis • Dermatology • Immunology • Seborrheic Dermatitis