Roflumilast

Eight of nine experts expressed feeling “extremely confident” about prescribing ZORYVE foam to patients of diverse skin and hair types, including individuals with previous hair treatments, based on review of formulation dataCrodafos™ CES, used in ZORYVE foam, is suitable for a wide variety of skin and hair typesFindings from this formulation review underscore the suitability of ZORYVE foam for use on all affected areas of the body, and all hair types, in the management of seborrheic dermatitis WESTLAKE VILLAGE, Calif., May 13, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, 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. “Seborrheic dermatitis is a common inflammatory skin condition that can affect individuals across all ages and demographics, and a spectrum of hair types. In addition, certain hair care practices can exacerbate the severity of the symptoms or complicate treatment options. As such, there is a significant need for versatile and well tolerated treatment options that do not interfere with the natural properties of hair and can effectively deliver therapeutic drug to the affected area including hair-bearing areas such as the scalp, or other areas of skin,” said Raj Chovatiya, MD, PhD, MSCI, associate professor at the Rosalind Franklin University Chicago Medical School, founder and director of the Center for Medical Dermatology and Immunology Research, and lead author of the publication. “These findings highlight that the ZORYVE foam formulation excludes harmful ingredients that are known to damage hair and includes a gentle emulsifier used for the first time in the pharmaceutical industry, which provides confidence in its use for patients without damaging the skin barrier or hair styles.” 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. In addition, Arcutis is the first company to formulate a pharmaceutical product with Crodafos CES, an emulsifier used in the skin and beauty industry due to its versatility and effectiveness across skin and hair types. Upon thorough review of the formulation data, eight out of nine experts expressed feeling “extremely confident” about using roflumilast foam with patients of diverse skin and hair types, including individuals with previous hair treatments. “ZORYVE foam was formulated with the patient in mind, as a once-daily application and water-based formulation excluding fragrances and other known irritants. We are pleased to see such a strong endorsement from the expert dermatological panel, who bring their medical and cosmetic expertise from clinical practice and research, on the formulation qualities of ZORYVE foam that make it compatible with all hair and skin types for the treatment of seborrheic dermatitis,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis. About Seborrheic DermatitisSeborrheic dermatitis affects up to 10 million people in the United States and is a common, chronic, and recurrent inflammatory skin disease that causes red patches covered with large, greasy, flaking yellow scales and persistent itch. Seborrheic dermatitis occurs most often in areas of the body with oil-producing (sebaceous) glands, including the scalp, face (especially on the nose, eyebrows, ears, and eyelids), upper chest, and back. About ZORYVE® FoamZORYVE foam is the first drug with a new mechanism of action approved for seborrheic dermatitis in over two decades. ZORYVE (roflumilast) topical foam, 0.3%, is indicated for treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. ZORYVE foam is a topical foam formulation of roflumilast, a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and is an established target in dermatology. INDICATIONZORYVE foam, 0.3%, is indicated for treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. IMPORTANT SAFETY INFORMATIONZORYVE 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%) include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).Please see full Prescribing Information. About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio including two FDA approved products that harness our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, and X. Forward-Looking StatementsArcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential of ZORYVE foam to simplify disease management for care of seborrheic dermatitis, and the potential of ZORYVE foam to work across skin and hair types and to become the standard of care in seborrheic dermatitis treatment. These statements are subject to substantial known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 27, 2024, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contacts:Media Amanda Sheldon, Head of Corporate Communicationsasheldon@arcutis.com Investors Latha Vairavan, Vice President, Finance and Investor Relationslvairavan@arcutis.com Derek ColeInvestor Relations Advisory Solutionsderek.cole@iradvisory.com