The Rheumatologist
COVID-19 NewsACR Convergence
  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed
  • Home
  • Conditions
    • Rheumatoid Arthritis
    • SLE (Lupus)
    • Crystal Arthritis
      • Gout Resource Center
    • Spondyloarthritis
    • Osteoarthritis
    • Soft Tissue Pain
    • Scleroderma
    • Vasculitis
    • Systemic Inflammatory Syndromes
    • Guidelines
  • Resource Centers
    • Axial Spondyloarthritis Resource Center
    • Gout Resource Center
    • Psoriatic Arthritis Resource Center
    • Rheumatoid Arthritis Resource Center
    • Systemic Lupus Erythematosus Resource Center
  • Drug Updates
    • Biologics & Biosimilars
    • DMARDs & Immunosuppressives
    • Topical Drugs
    • Analgesics
    • Safety
    • Pharma Co. News
  • Professional Topics
    • Ethics
    • Legal
    • Legislation & Advocacy
    • Career Development
      • Certification
      • Education & Training
    • Awards
    • Profiles
    • President’s Perspective
    • Rheuminations
    • Interprofessional Perspective
  • Practice Management
    • Billing/Coding
    • Quality Assurance/Improvement
    • Workforce
    • Facility
    • Patient Perspective
    • Electronic Health Records
    • Apps
    • Information Technology
    • From the College
    • Multimedia
      • Audio
      • Video
  • Resources
    • Issue Archives
    • ACR Convergence
      • Gout Resource Center
      • Axial Spondyloarthritis Resource Center
      • Psoriatic Arthritis
      • Abstracts
      • Meeting Reports
      • ACR Convergence Home
    • American College of Rheumatology
    • ACR ExamRheum
    • Research Reviews
    • ACR Journals
      • Arthritis & Rheumatology
      • Arthritis Care & Research
      • ACR Open Rheumatology
    • Rheumatology Image Library
    • Treatment Guidelines
    • Rheumatology Research Foundation
    • Events
  • About Us
    • Mission/Vision
    • Meet the Authors
    • Meet the Editors
    • Contribute to The Rheumatologist
    • Subscription
    • Contact
  • Advertise
  • Search
You are here: Home / Articles / FDA Approves Combination Therapy for OA Pain, but Not Duobrii Lotion for Plaque Psoriasis

FDA Approves Combination Therapy for OA Pain, but Not Duobrii Lotion for Plaque Psoriasis

July 9, 2018 • By Michele B. Kaufman, PharmD, BCGP

  • Tweet
  • Email
Print-Friendly Version / Save PDF

The U.S. Food and Drug Administration (FDA) has taken regulatory action on treatments for rheumatic disease. The agency approved a combination of amlodipine and celecoxib for treating osteoarthritis (OA) pain and hypertension; however, it did not approve a combination of halobetasol propionate and tazarotene lotion for plaque psoriasis.

You Might Also Like
  • FDA Update: Topical Plaque Psoriasis Treatment Approved; Dupilumab Will Receive FDA Priority Review
  • U.S. FDA Approves Lilly’s Ixekizumab for Plaque Psoriasis
  • FDA Approves Valeant’s Drug to Treat Plaque Psoriasis
Also By This Author
  • Etanercept Biosimilar Approved in EU, Plus FDA Reviews Brodalumab for Plaque Psoriasis

FDA Approves Combination Amlodipine & Celecoxib
On May 31, the FDA approved a combination of amlodipine and celecoxib (Consensi) for treating OA pain and hypertension.1 The combination therapy is approved for once daily use and will be available in three doses: 2.5 mg amlodipine/200 mg celecoxib, 5 mg amlodipine/200 mg celecoxib and 10 mg amlodipine/200 mg celecoxib.

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

The approval was based on data from a phase 3 clinical trial, which demonstrated the lowering of daytime systolic blood pressure by a minimum of 50% in amlodipine/celecoxib-treated patients compared with amlodipine-treated patients. This primary endpoint was statistically significant (P=0.001).

Additional positive study results from a randomized double-blind, placebo-controlled, phase 3/4 renal function trial were submitted by the manufacturer to the FDA. This trial showed amlodipine/celecoxib treatment leading to a statistically significant serum creatinine reduction from baseline (P=0.0005). Treated patients showed improved renal function. Neither amlodipine besylate monotherapy nor placebo lowered serum creatinine to a statistically significant level. Additionally, the data from this study validated the primary efficacy endpoint achieved in the phase 3 trial noted above.

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

Halobetasol Propionate & Tazarotene Lotion Not Approved
In June, Valeant Pharmaceuticals received a complete response letter from the FDA regarding its new drug application for Duobrii lotion, a combination of halobetasol propionate and tazarotene intended to treat plaque psoriasis.2 The letter did not specify any clinical efficacy or safety issues with the product, but did pose questions regarding pharmacokinetic data.

Duobrii (IDP-118) was submitted for FDA approval in 2017, with the FDA accepting the filing in November.3 Phase 3 data from January 2017 showed significantly higher rates of treatment success with Duobrii, partially defined as obtaining a clear to almost clear skin score, when compared with placebo. The study was in adults with moderate to severe psoriasis who received eight weeks of treatment and four weeks of follow-up.

The manufacturer has requested a meeting with the FDA to answer any remaining questions.

ad goes here:advert-3
ADVERTISEMENT
SCROLL TO CONTINUE

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

  1. Kitov Pharmaceuticals Ltd. U.S. Food and Drug Administration (FDA) has approved Consensi (amlodipine and celecoxib) oral tablets for marketing. 2018 May 31.
  2. Valeant Pharmaceuticals Inc. FDA issues complete response letter for Duobrit (halobetasol propionate and tazarotene) lotion. 2018 Jun 18.
  3. Barber J. FDA rejects approval of Valeant’s Duobrii for plaque psoriasis over pharmacokinetic data. FirstWord Pharma. 2018 Jun 18.

Pages: 1 2 | Multi-Page

Filed Under: Analgesics, DMARDs & Immunosuppressives, Drug Updates Tagged With: Consensi, Duobrii, FDA approval, hypertension, osteoarthritis (OA), Pain, Pain Management, U.S. Food and Drug Administration (FDA)

You Might Also Like:
  • FDA Update: Topical Plaque Psoriasis Treatment Approved; Dupilumab Will Receive FDA Priority Review
  • U.S. FDA Approves Lilly’s Ixekizumab for Plaque Psoriasis
  • FDA Approves Valeant’s Drug to Treat Plaque Psoriasis
  • Certolizumab Pegol Receives FDA Approval for Plaque Psoriasis

American College of Rheumatology

Visit the official website for the American College of Rheumatology.

Visit the ACR »

Rheumatology Research Foundation

The Foundation is the largest private funding source for rheumatology research and training in the U.S.

Learn more »

ACR Convergence

Don’t miss rheumatology’s premier scientific meeting for anyone involved in research or the delivery of rheumatologic care or services.

Visit the ACR Convergence site »

The Rheumatologist newsmagazine reports on issues and trends in the management and treatment of rheumatic diseases. The Rheumatologist reaches 11,500 rheumatologists, internists, orthopedic surgeons, nurse practitioners, physician assistants, nurses, and other healthcare professionals who practice, research, or teach in the field of rheumatology.

About Us / Contact Us / Advertise / Privacy Policy / Terms of Use / Cookie Preferences

  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed

Copyright © 2006–2023 American College of Rheumatology. All rights reserved.

ISSN 1931-3268 (print)
ISSN 1931-3209 (online)