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 / Hydrocodone Bitartrate, Secukinumab, Varenicline Updates, Trials, Approvals

Hydrocodone Bitartrate, Secukinumab, Varenicline Updates, Trials, Approvals

December 1, 2014 • By Michele B. Kaufman, PharmD, BCGP

  • Tweet
  • Email
Print-Friendly Version / Save PDF

Hydrocodone bitartrate (Zohydro ER) with modified formulation designed with abuse-deterrent properties has been submitted to the FDA as a supplemental New Drug Application (sNDA).1 This new capsule formulation contains additional inactive ingredients that are intended to make the product more difficult to abuse by injection and nasal insufflation. The manufacturer anticipates review of their submission in the first quarter of 2015. If approved, this product will replace the currently marketed product that does not have abuse-deterrent properties. The product is indicated for managing pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are not adequate.

You Might Also Like
  • Decernotinib, Subcutaneous Methotrexate Drug Updates, Trials, Approvals
  • Rheumatology Drug Updates: Efficacy Studied Following Accelerated Drug Approvals; Plus Secukinumab Meets Benchmark for Psoriasis
  • Ixekizumab Clinical Trials Continue; FDA Updates Warning Label for Varenicline
Explore This Issue
December 2014
Also By This Author
  • FDA Approves Celecoxib in an Oral Solution

Secukinumab (AIN457) is a fully human monoclonal antibody that selectively blocks IL-17A.2 Secukinumab in patients with adult-onset psoriatic arthritis (PsA) has met primary and major secondary endpoints in two pivotal Phase 3 clinical trials (FUTURE 1 and FUTURE 2), showing superiority to placebo in over 1,000 patients. Endpoints included improving PsA signs and symptoms, preventing joint damage and improving peripheral joint disease, compared with placebo. While at the same time, patients had clear or almost clear skin (Psoriasis Area Severity Index 90). Both FUTURE 1 and 2 are randomized, placebo-controlled, multicenter studies designed to establish secukinumab efficacy in PsA patients in comparison to placebo. In addition, the studies were designed to assess secukinumab tolerability and safety. The ACR20 was the primary endpoint in these trials, and the agent was well tolerated. No new safety signals were identified. It is also being investigated to treat ankylosing spondylitis (AS), moderate-to-severe plaque psoriasis and rheumatoid arthritis (RA).

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

On Sept. 18, a combined Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement of FDA met to discuss limitation on the use of testosterone products.3 They unanimously voted on modifying product labeling for testosterone-replacement products used for men with congenital or acquired primary hypogonadism, including such conditions as cryptorchidism, Klinefelter’s syndrome or testicular damage from chemotherapy or heavy metals. These uses were not questioned.

The benefit of [testosterone-replacement products] is unknown in patients with idiopathic hypogonadism.

Use for “age-related or idiopathic” hypogonadism was questioned. This is currently worded as “hypo­gonadotropic hypogonadism (congenital or acquired): Idiopathic gonadotropin or luteinizing-hormone–releasing (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.” The panel recommended the completion of large studies to show both clinical benefit and product safety. Currently, the benefit is unknown in patients with idiopathic hypogonadism. The ambiguous wording has led to increased testosterone use in men with potentially low testosterone (low-T) who have signs and symptoms of age-related low levels, but many have normal levels or have not had their levels tested. In addition, studies have shown that testosterone use may increase cardiovascular risk in men who use the product. Additionally, in 25% of testosterone-replacement product users, no levels were obtained prior to treatment, and 21% of users never had levels checked during treatment.

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

Pages: 1 2 3 | Single Page

Filed Under: Analgesics, Conditions, Drug Updates, Rheumatoid Arthritis, Safety, Spondyloarthritis Tagged With: Ankylosing Spondylitis, Approval, drug, FDA, hydrocodone bitartrate, Kaufman, labs, Pain, Research, Rheumatoid arthritis, rheumatology, secukinumab, vareniclineIssue: December 2014

You Might Also Like:
  • Decernotinib, Subcutaneous Methotrexate Drug Updates, Trials, Approvals
  • Rheumatology Drug Updates: Efficacy Studied Following Accelerated Drug Approvals; Plus Secukinumab Meets Benchmark for Psoriasis
  • Ixekizumab Clinical Trials Continue; FDA Updates Warning Label for Varenicline
  • Rheumatology Drug Updates, Trials, Safety Data

Simple Tasks

Learn more about the ACR’s public awareness campaign and how you can get involved. Help increase visibility of rheumatic diseases and decrease the number of people left untreated.

Visit the Simple Tasks site »

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 »

American College of Rheumatology

Visit the official website for the American College of Rheumatology.

Visit the ACR »

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)