PDE4

Study Showing Significant Improvements in Itch and Itch-Related Sleep Loss with Roflumilast Cream in Adults with Plaque Psoriasis Published in American Journal of Clinical Dermatology

Retrieved on: 
Monday, November 28, 2022

In the parallel-group, double-blind, vehicle-controlled phase 2b clinical trial, 331 subjects ranging from ages 18 to 89 years were randomized to roflumilast 0.3% cream, roflumilast 0.15% cream or vehicle in a 1:1:1 ratio.

Key Points: 
  • In the parallel-group, double-blind, vehicle-controlled phase 2b clinical trial, 331 subjects ranging from ages 18 to 89 years were randomized to roflumilast 0.3% cream, roflumilast 0.15% cream or vehicle in a 1:1:1 ratio.
  • Roflumilast cream or vehicle was applied once daily to all psoriasis lesions for 12 weeks.
  • In July 2022, ZORYVE (roflumilast) cream 0.3% was approved for the topical use in adults and adolescents with mild to severe plaque psoriasis, including intertriginous psoriasis.
  • ZORYVE (roflumilast) cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

Arcutis’ ZORYVE® (Roflumilast) Cream 0.3% Added to Express Scripts, Inc.® National Formularies in the United States

Retrieved on: 
Thursday, November 17, 2022

Express Scripts commercial national formularies provide access to more than 26 million commercial lives in the United States.

Key Points: 
  • Express Scripts commercial national formularies provide access to more than 26 million commercial lives in the United States.
  • Ensuring affordable access to ZORYVE is of the utmost priority for Arcutis.
  • The inclusion of ZORYVE on Express Scripts national formularies means that our next-generation topical PDE4 inhibitor is now available as a new topical treatment option for millions of adults and adolescents in the United States living with plaque psoriasis, said Frank Watanabe, President and CEO of Arcutis.
  • Were excited by our progress to date and our ability to secure this coverage for ZORYVE with Express Scripts national formularies prior to the end of the year.

Arcutis Announces Positive Topline Results from INTEGUMENT-1 Pivotal Phase 3 Trial of Roflumilast Cream in Atopic Dermatitis in Adults and Children Aged Six Years and Older

Retrieved on: 
Tuesday, November 15, 2022

In this pivotal Phase 3 study, roflumilast cream demonstrated strong efficacy, meeting the primary endpoint of IGA success, and was well tolerated.

Key Points: 
  • In this pivotal Phase 3 study, roflumilast cream demonstrated strong efficacy, meeting the primary endpoint of IGA success, and was well tolerated.
  • Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States.
  • Atopic dermatitis (AD) is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the U.S.
  • For atopic dermatitis, roflumilast cream is being evaluated at lower doses: 0.15% for adults and children six years of age and older and 0.05% for children two to five years.

Arcutis Announces Third Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, November 8, 2022

Effective November 2022, ZORYVE is now covered by one of the top pharmacy benefit managers and a large national health plan.

Key Points: 
  • Effective November 2022, ZORYVE is now covered by one of the top pharmacy benefit managers and a large national health plan.
  • In September 2022, Arcutis announced positive topline results from the ARRECTOR pivotal Phase 3 trial for the treatment of scalp and body psoriasis.
  • Ms. Krishnamohan brings a depth of business, financial and investment experience, including deep knowledge of Arcutis' business having previously worked on the Company's initial public offering.
  • Arcutis management will host a conference call and webcast today at 5:00pm ET to discuss the financial results for the quarter and provide a business update.

Cerevel Therapeutics Reports Third Quarter 2022 Financial Results and Business Updates

Retrieved on: 
Tuesday, November 8, 2022

ET

Key Points: 
  • ET
    CAMBRIDGE, Mass., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Cerevel Therapeutics , (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, today reported financial results for the quarter ended September 30, 2022 and provided key pipeline and business updates.
  • In June 2022, Cerevel initiated its Phase 2 program in schizophrenia, in which emraclidine is being studied as a once-daily medication without the need for titration.
  • In the second quarter of 2021, Cerevel received Fast Track designation from the FDA for the development of CVL-871 in dementia-related apathy.
  • ET to discuss its third quarter 2022 financial results and pipeline updates.

Arcutis Announces Positive Topline Results from ARRECTOR Pivotal Phase 3 Trial of Roflumilast Foam 0.3% in Scalp and Body Psoriasis

Retrieved on: 
Monday, September 26, 2022

Roflumilast foam is a selective and potent PDE4 inhibitor that has been uniquely formulated as an emollient, water-based, moisturizing foam that can be used on the scalp and body.

Key Points: 
  • Roflumilast foam is a selective and potent PDE4 inhibitor that has been uniquely formulated as an emollient, water-based, moisturizing foam that can be used on the scalp and body.
  • These data demonstrate that investigational roflumilast foam, if approved, could provide both an effective and well-tolerated new treatment option for scalp and body psoriasis.
  • Roflumilast foam was well-tolerated, and the overall safety and tolerability profile was consistent with previously published studies of roflumilast cream 0.3% and foam.
  • Roflumilast foam is a once-daily topical foam formulation of roflumilast which the Company is developing for both seborrheic dermatitis and scalp and body psoriasis.

Journal of the American Medical Association Publishes Roflumilast Cream 0.3% Results from Pivotal DERMIS-1 and -2 Phase 3 Trials in Plaque Psoriasis

Retrieved on: 
Tuesday, September 20, 2022

ZORYVE was approved for topical use of plaque psoriasis, including intertriginous psoriasis, for use in adults and adolescents in July 2022.

Key Points: 
  • ZORYVE was approved for topical use of plaque psoriasis, including intertriginous psoriasis, for use in adults and adolescents in July 2022.
  • These data highlight the robust efficacy of ZORYVE as a novel non-steroidal treatment option for individuals with plaque psoriasis.
  • We are thrilled that such a prestigious journal has published the results of our pivotal Phase 3 trials.
  • ZORYVE (roflumilast) cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

New Data from Arcutis’ STRATUM Pivotal Phase 3 Trial of Roflumilast Foam 0.3% in Seborrheic Dermatitis Presented at European Academy of Dermatology and Venereology (EADV) Congress

Retrieved on: 
Friday, September 9, 2022

Roflumilast foam demonstrated strong efficacy across multiple endpoints, including 50% of individuals with seborrheic dermatitis achieving IGA clear at week 8.

Key Points: 
  • Roflumilast foam demonstrated strong efficacy across multiple endpoints, including 50% of individuals with seborrheic dermatitis achieving IGA clear at week 8.
  • Roflumilast foam also demonstrated statistically significant improvements compared to vehicle on all secondary endpoints in the trial, including itch, scaling, and erythema (redness).
  • (63.6% with roflumilast foam vs 42.3% vehicle (P=0.0002))
    More than 50% of individuals treated with roflumilast foam achieved an erythema score of 0 at week 8.
  • Roflumilast foam is a once-daily topical foam formulation of roflumilast which the Company is developing for both seborrheic dermatitis and scalp and body psoriasis.

New Data from Arcutis’ Topical Roflumilast Clinical Program Presented at the European Academy of Dermatology and Venereology (EADV) Congress

Retrieved on: 
Tuesday, September 6, 2022

Specifically, new data from the STRATUM Phase 3 pivotal trial of roflumilast foam in seborrheic dermatitis will be presented in a late-breaking news session.

Key Points: 
  • Specifically, new data from the STRATUM Phase 3 pivotal trial of roflumilast foam in seborrheic dermatitis will be presented in a late-breaking news session.
  • Roflumilast foam is a once-daily topical foam formulation of roflumilast which the Company is developing for both seborrheic dermatitis and scalp and body psoriasis.
  • ZORYVE (roflumilast) cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.
  • Arcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements.

Arcutis Completes Enrollment in INTEGUMENT-2 Pivotal Phase 3 Trial of Roflumilast Cream in Atopic Dermatitis

Retrieved on: 
Tuesday, August 23, 2022

Roumilast cream is a once daily topical formulation of roumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4).

Key Points: 
  • Roumilast cream is a once daily topical formulation of roumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4).
  • The Company completed enrollment in an identically designed pivotal Phase 3 trial, INTEGUMENT-1, earlier in August 2022, with topline data from both trials expected by end of 2022.
  • Atopic dermatitis is the most common type of eczema, aecting approximately 9.6 million children and 16.5 million adults in the United States.
  • We are excited to have completed enrollment in the second of two phase 3 pivotal trials with roflumilast cream 0.15% in individuals with atopic dermatitis age six years and older, just weeks after closing enrollment for INTEGUMENT-1.