PDE4

Arcutis Completes Enrollment in INTEGUMENT-PED Pivotal Phase 3 Trial of Roflumilast Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5

Retrieved on: 
Tuesday, May 2, 2023
PDE4, Irritant, Dermatitis, Sleep, NDA, Doctor of Philosophy, FAAD, Shanda, MD, Pivotal, Ageing, Itch, AD, Safety, Disease, Dietary supplement

Arcutis previously reported positive topline data in similarly designed Pivotal Phase 3 trials of roflumilast cream 0.15% in ages 6 and above.

Key Points: 
  • Arcutis previously reported positive topline data in similarly designed Pivotal Phase 3 trials of roflumilast cream 0.15% in ages 6 and above.
  • “Topical steroids are the first-line of treatment for AD in children, and there are few treatment options available for chronic use.
  • “Roflumilast cream is a once-daily, steroid free treatment that was formulated to be a non-greasy, moisturizing cream that absorbs quickly.
  • Arcutis plans to submit the new drug application (NDA) for roflumilast cream 0.15% for adults and children age 6 and older in the second half of 2023.

Arcutis Announces Canadian Approval of ZORYVE™ (roflumilast) Cream 0.3% for Treatment of Plaque Psoriasis in Individuals 12 Years and Older

Retrieved on: 
Friday, April 28, 2023
PDE4, Partnership, Dermatology, Psoriasis, Assistant professor, United, Principal, Health Canada, Groin, Pharmaceutical industry

In Canada, ZORYVE is indicated for topical treatment of plaque psoriasis, including treatment of psoriasis in the intertriginous areas, in individuals 12 years of age and older.

Key Points: 
  • In Canada, ZORYVE is indicated for topical treatment of plaque psoriasis, including treatment of psoriasis in the intertriginous areas, in individuals 12 years of age and older.
  • “The successful approval of ZORYVE in Canada is a testament to Arcutis’ continued commitment to provide therapies that address the most persistent challenges for individuals with immune-mediated skin diseases.
  • We are proud to bring this important new steroid-free cream to Canada, where there is a need for safe and effective topical treatment for plaque psoriasis,” said Frank Watanabe, President and CEO of Arcutis.
  • Today’s announcement marks a significant commercial milestone as the first regulatory approval of ZORYVE outside of the United States.

Arcutis Announces FDA Acceptance of New Drug Application for Roflumilast Foam 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older

Retrieved on: 
Tuesday, April 18, 2023
Human, PDE4, Success, Study, Seborrhoeic dermatitis, Face, NDA, Reduction-sensitive nanoparticles, Scalp, Nose, Dermatitis, Eyebrow, IGA, Eyelid, Phase 3, Dermatology, PDUFA, Itch, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Disease, Pharmaceutical industry, Cosmetics

The application was assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2023.

Key Points: 
  • The application was assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2023.
  • Roflumilast foam was designed to address these shortcomings, as a once-daily, steroid-free topical drug that can be used chronically anywhere on the body.
  • The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) was the pivotal Phase 3, parallel group, double-blind, vehicle-controlled study evaluating the safety and efficacy of roflumilast foam 0.3% in seborrheic dermatitis.
  • In addition, 51.3% of individuals in the roflumilast foam treated arm reached complete clearance at Week 8.

Arcutis Announces New Coverage for ZORYVE® (Roflumilast) Cream 0.3% with National and Regional Health Plan Formularies, Bringing Total Commercial Covered Lives to Over 110 Million

Retrieved on: 
Wednesday, April 5, 2023
PDE4, Plaque, Face, Psoriasis, Dermatology, Patient, Dietary supplement, Health insurance

Combined with the previously announced coverage from two of the three largest national pharmacy benefit managers and several large national health plans, commercial coverage for ZORYVE for plaque psoriasis now exceeds 110 million commercially covered lives in the United States.

Key Points: 
  • Combined with the previously announced coverage from two of the three largest national pharmacy benefit managers and several large national health plans, commercial coverage for ZORYVE for plaque psoriasis now exceeds 110 million commercially covered lives in the United States.
  • The vast majority of individuals with plaque psoriasis use topical therapies, and until recently there were few steroid-free options.
  • ZORYVE, a once-daily, steroid-free PDE4 inhibitor cream, provides rapid results for both hard-to-treat areas, such as knees and elbows, and sensitive areas such as the face, intertriginous areas, and genitalia.
  • This commercial coverage, which requires no prior authorization, provides a further proof point that our responsible pricing strategy is resonating with payers,” said Frank Watanabe, President and CEO of Arcutis.

Arcutis Presents Late-Breaking Data from the INTEGUMENT Phase 3 Trials in Atopic Dermatitis at American Academy of Dermatology Annual Meeting

Retrieved on: 
Saturday, March 18, 2023
PDE4, American Academy of Dermatology, Arm, AD, Atopic dermatitis, American Academy, AAD, Week, Vaccine

Roflumilast cream is a once-daily, steroid-free topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor.

Key Points: 
  • Roflumilast cream is a once-daily, steroid-free topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor.
  • Over 30% of individuals treated with roflumilast cream in each study achieved Worst Itch Numeric Scale (WI-NRS) Success at Week 4.
  • “Roflumilast cream was also shown to be safe and well-tolerated, critical considerations for the treatment of atopic dermatitis.
  • Local tolerability was favorable with more than 90% of those treated with roflumilast cream reporting no or mild sensation across arms in both trials at any timepoint.

Arcutis Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, February 28, 2023
Janus, Skin, Hair, SG, Psoriasis, ESG, Research, Vitiligo, Acquisition, JAK1, Webcast, FDA, Patient, R, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Biophysical environment, Scalp, NDA, Growth, Inflammation, PDE4, Prescription, New Drug Application, Shanda, Pharmacy, Alopecia areata, Food, Ageing, Dermatitis, Atopic dermatitis, Video game, Health insurance, Pharmaceutical industry, Cosmetics, Cryptocurrency

In the fourth quarter of 2022, Arcutis announced positive topline results from INTEGUMENT-1 and INTEGUMENT-2, the two pivotal Phase 3 trials evaluating roflumilast cream 0.15% for the treatment of atopic dermatitis in individuals 6 years of age or older.

Key Points: 
  • In the fourth quarter of 2022, Arcutis announced positive topline results from INTEGUMENT-1 and INTEGUMENT-2, the two pivotal Phase 3 trials evaluating roflumilast cream 0.15% for the treatment of atopic dermatitis in individuals 6 years of age or older.
  • In September 2022, Arcutis announced positive topline results from the ARRECTOR pivotal Phase 3 trial for the treatment of scalp and body psoriasis.
  • Net cash used in operating activities was $71.1 during the fourth quarter and $257.7 million during the full year 2022.
  • Arcutis management will host a conference call and webcast today at 4:30pm ET to discuss the financial results for the quarter and provide a business update.

Cerevel Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Business Updates

Retrieved on: 
Wednesday, February 22, 2023
D, Panic disorder, Brain, Investment, PIN, DSM-IV codes, Conference call, Safety, Disorder, PAM, Schizophrenia, Therapy, Hallucination, FDA, Psychiatry, Growth, GABAA, PDE4, Research, Epilepsy, KORA, Conference, Delusion, Blood pressure, Pharmacokinetics, Cryptocurrency, Pharmaceutical industry, Video game, G&A

ET

Key Points: 
  • ET
    CAMBRIDGE, Mass., Feb. 22, 2023 (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 fourth quarter and full year ended December 31, 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.
  • Cerevel expects G&A expenses to remain relatively consistent for 2023, as compared to the fourth quarter of 2022.
  • ET to discuss its fourth quarter and full year 2022 financial results and pipeline updates.

Arcutis Submits Topical Roflumilast Foam 0.3% New Drug Application to the FDA for the Treatment of Seborrheic Dermatitis in Adults and Adolescents

Retrieved on: 
Tuesday, February 21, 2023
Nose, NDA, Week, Eyebrow, Eyelid, Human, Safety, Face, Scalp reduction, Study, Food, Dermatitis, Seborrhoeic dermatitis, Disease, FDA, Scalp, PDE4, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmaceutical industry, Cosmetics

Arcutis recognizes the urgent need for a new therapy that could enable symptom control, easier management, and increased adherence,” said Patrick Burnett M.D., Ph.D, F.A.A.D., Chief Medical Officer at Arcutis.

Key Points: 
  • Arcutis recognizes the urgent need for a new therapy that could enable symptom control, easier management, and increased adherence,” said Patrick Burnett M.D., Ph.D, F.A.A.D., Chief Medical Officer at Arcutis.
  • “Roflumilast foam, which is being developed as an easy-to-use, steroid free, once-daily topical treatment, has been shown in clinical trials to be effective and well tolerated.
  • “There has not been a once-daily steroid-free topical prescription treatment approved for seborrheic dermatitis in over a decade.
  • The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) was a Phase 3, parallel group, double blind, vehicle-controlled study evaluating the safety and efficacy of roflumilast foam 0.3%.

Giiant Pharma Receives Financial Support From the US Crohn’s and Colitis Foundation

Retrieved on: 
Tuesday, January 10, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, IND, Inflammatory Bowel Diseases, Colitis, PDE4, Ulcerative colitis, IBD, Therapy, Patient, US, Multimedia, Pharmaceutical industry

Giiant Pharma Inc., a Canadian, preclinical-stage biotech company, today announced that the Company will receive financial support from the US Crohn’s and Colitis Foundation, through its IBD Ventures program, for an amount up to US$ 500,000.

Key Points: 
  • Giiant Pharma Inc., a Canadian, preclinical-stage biotech company, today announced that the Company will receive financial support from the US Crohn’s and Colitis Foundation, through its IBD Ventures program, for an amount up to US$ 500,000.
  • This financing will support the development of GT-2108, an orally administered, gut-restricted, colon-specific PDE4 (phosphodiesterase-4) inhibitor prodrug for patients affected by moderate-to-severe ulcerative colitis.
  • “The financial support of the Crohn’s and Colitis Foundation demonstrates the strong Giiant’s value proposition of its platform for patients suffering from inflammatory bowel diseases, including ulcerative colitis” says Dr. Maxime Ranger, President and CEO of Giiant Pharma Inc.
    With this financing, Giiant Pharma will pursue its IND-enabling preclinical program with its lead candidate, GT-2108, in view of an IND filing by Q2 2024.
  • The Company is currently in discussion with potential pharmaceutical partners to co-develop and accelerate the GT-2108 program.

Arcutis Presents New Phase 2 Long-Term Data Showing Sustained Efficacy and Clearance for a Median of 10 Months with Roflumilast Cream in Adults with Chronic Plaque Psoriasis

Retrieved on: 
Saturday, January 14, 2023
Kimberley, FAAD, Common, URTI, IGA, Therapy, Icahn School of Medicine at Mount Sinai, Safety, Sinusitis, PDE4, MD, FDA, Irritation, Psoriasis, Urinary tract infection, Patient, Tachyphylaxis, AES, US Foods, Doctor of Philosophy, Mount Sinai, Cosmetics, Pharmaceutical industry, Dermatology

Roflumilast cream 0.3% (ZORYVE®) is a once-daily steroid free topical phosphodiesterase-4 (PDE4) inhibitor approved by the US Food and Drug Administration in July 2022.

Key Points: 
  • Roflumilast cream 0.3% (ZORYVE®) is a once-daily steroid free topical phosphodiesterase-4 (PDE4) inhibitor approved by the US Food and Drug Administration in July 2022.
  • Roflumilast cream was safe and very well tolerated, with the majority of adverse events (AEs) mild-to-moderate in severity.
  • Additional key findings following 52 weeks of treatment with roflumilast cream 0.3% include:
    IGA success was achieved by 35.3% of participants previously treated with roflumilast cream and 37.5% of roflumilast-naïve participants.
  • 1Cohort 1 not shown because I-IGA added as study amendment and numbers of patients evaluated are very small at each timepoint.