FDA to Review Abuse-Deterrent Oxycodone Capsule In June, the FDA will discuss the New Drug Application for Remoxy ER at an Advisory Committee meeting. Remoxy ER is a 12-hour, abuse-deterrent, extended-release oxycodone in a capsule formulation.1 The capsule contains a sticky, thick, high-viscosity formulation to deter unapproved drug administration routes, including injection, smoking or snorting….
Certain medications have been associated for decades with the development of drug-induced autoimmunity. New research published in March 2018 in Arthritis & Rheumatology suggests that NETs (neutrophil extracellular traps) are potentially implicated in the mechanisms that lead to drug-induced autoimmunity.1 Peter Grayson, MD, MSc, head of the Vasculitis Translational Research Program at the National Institute…
Since they were first introduced in 2011, immune checkpoint inhibitors (ICIs) have become an important treatment for an expanding list of advanced cancers. Some concerns have been raised around the mechanism of action of these immunotherapy agents, making their use in rheumatic diseases (RD) problematical. An article in the March 2018 issue of Arthritis &…
In July 2017, Todd A. Graham, MD, a practicing orthopedic surgeon in South Bend, Ind., was fatally shot after getting into a heated dispute with a patient and her husband over a requested opioid prescription.1 The murder of Dr. Graham is a tragic example of the potential dangers of physician-patient disagreements. Rheumatology patients often endure…
A yearlong pilot study that evaluated the safety and efficacy of belimumab in a small group of patients with early diffuse systemic sclerosis found no significant difference in the number of adverse events between those treated with the drug and those who received a placebo. Currently, no drugs are approved specifically for the treatment of…
After an independent review, ongoing clinical trials investigating the safety of fasinumab for treating hip or knee OA will discontinue the use of higher fasinumab doses…
NEW YORK (Reuters Health)—Romosozumab shows smaller benefits for increasing bone mineral density (BMD) in the second year of treatment compared to the first, new research suggests. The extension of a phase 2 study in postmenopausal women with low bone mass also found BMD decreased sharply when patients on romosozumab were switched to placebo after two…
The FDA Arthritis Advisory Committee has recommended the approval of 2 mg baricitinib (but not in a 4 mg dose) for treating adults with moderate to severe active RA…
In Japan the use of guselkumab to treat erythrodermic, plaque and pustular psoriasis is approved, and anakinra is now indicated for Still’s disease in the E.U…