The FDA has approved a new drug application for TNX-102 SL (Tonmya), a tablet with 2.8 mg of cyclobenzaprine HCl, after two clinical trials demonstrated the safety and effectiveness of the treatment in adults with fibromyalgia.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer and editor. She is also a pharmacist at New York Presbyterian Hospital–Lower Manhattan campus. She has been a past guest lecturer at Touro College of Pharmacy in New York City for the Medical Writing elective. Dr Kaufman is a member of the New York City Society of Health-Systems Pharmacy, the New York State Council of Health-System Pharmacists, the Academy of Managed Care Pharmacy (AMCP)—Northeast Region Affiliate Chapter, the American Society of Consultant Pharmacists and the Empire State-Metropolitan NY Chapter of the American Medical Writers Association. She received her BS in Pharmacy from the University of Rhode Island (URI) College of Pharmacy and her Doctor of Pharmacy degree from Massachusetts College of Pharmacy and Allied Health Sciences in Boston. She also completed a Drug Information Fellowship at the URI Drug Information Center/Roger Williams Medical Center in Providence, R.I. Dr Kaufman is a registered pharmacist and is a Board-Certified Geriatric Pharmacist.
Articles by Michele B. Kaufman, PharmD, BCGP
Dazodalibep for Sjögren’s Disease
St.Clair et al. found that patients with Sjögren’s disease treated with dazodalibep experienced greater improvement in key symptoms of dryness, fatigue & pain than patients who received placebo.
New FDA Label Requirements for Opioids
After reviewing data from post-marketing observational studies, the FDA has issued new labeling requirements for opioids with the goal of emphasizing and explaining the risks associated with long-term use.
Promising Phase 2 Results for Efgartigimod alfa-fcab in Adults with Primary Sjögren’s Disease
A study from Peene et al. found that patients with primary Sjögren’s disease experienced significant improvements in systemic disease activity and symptoms when treated with intravenous efgartigimod alfa-fcab.
FDA Approves Ustekinumab-stba for All Forms & Dosages as Its Reference Product
Ustekinumab-stba (Steqeyma) now has FDA approval for all forms and dosages of its reference product, ustekinumab (Stelara), including a subcutaneous injection to treat pediatric patients with plaque psoriasis or psoriatic arthritis.
Positive Week 12 Results for Rosnilimab in Patients with RA
Early study results demonstrate that rosnilimab may be safe and effective for patients with rheumatoid arthritis, reducing the signs and symptoms of RA by week 12 and achieving important primary and secondary study end points.
Biosimilar Update: 2025 Brings More FDA Approvals & Interchangeability
Here is a brief recap of the latest FDA-approved biosimilar agents, highlighting their reference products and interchangeability.
FDA Approves Upadacitinib for GCA
Supported by data in patients with new-onset and relapsing giant cell arteritis (GCA), the FDA approved upadacitinib for the treatment of adults with GCA.
FDA Approvals: Lupus Nephritis
Lupus nephritis is one of the leading causes of mortality for patients with systemic lupus erythematosus (SLE), and patients with both SLE and end-stage renal disease have standardized mortality ratios more than 60 times that of patients with SLE with normal kidney function.1 The good news: Rheumatologists now have not one, but two approved options…
Trials Find Potential Treatments for SLE, Lupus Nephritis
In summer 2024, two phase 3 studies were released with promising findings for the treatment of patients with systemic lupus erythematosus (SLE) and those with lupus nephritis. SLE Disease Activity Dapirolizumab pegol is a novel, investigational, Fc-free anti-CD40L agent for people living with moderate to severe SLE.1 The randomized, double-blind, parallel-group PHOENYCS GO trial (N=321)…
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