(Reuters)—Drugmaker Regeneron Pharmaceuticals Inc. said on Monday its experimental drug to treat moderate to severe osteoarthritis pain was successful in a late-stage study. The drug, fasinumab, was tested on 421 patients with a history of inadequate pain relief or intolerance to current painkillers. Fasinumab binds to nerve growth factor (NGF) proteins and block their activity,…
Medical Cannabis Helps Chronic Pain Patients Cut Opioid Use
NEW YORK (Reuters Health)—Medical cannabis reduces chronic pain patients’ opioid use, while improving their quality of life, according to a new survey of Michigan cannabis dispensary patrons. “They report that when they make that switch they overall feel better,” Dr. Daniel J. Clauw of the University of Michigan, Ann Arbor, told Reuters Health in a…
FDA Says It Requires Boxed Warning on Some Opioid-Based Painkillers
(Reuters)—The U.S. Food and Drug Administration announced on Tuesday new required class-wide safety labeling changes for immediate-release opioid pain medications. Among the changes, the FDA now requires these pain medications to carry a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. The FDA also requires several additional safety labeling…
U.S. Agency Issues New Guidelines to Limit Chronic Use of Opioids
(Reuters)—Addressing a growing “epidemic” of opioid overdoses and abuse of the prescribed painkillers in the U.S., the Centers for Disease Control and Prevention on Tuesday released voluntary guidelines that instruct primary care doctors to sharply deter use of the medicines for chronic pain. “Overprescribing opioids, largely for chronic pain, is a key driver of America’s…
Rheumatology Drug Updates: Opioid CR845 for OA Pain; RA Treatments in Development
CR845—an oral, peripherally selective kappa opioid agonist—is currently in Phase 2 trials for the treatment of pruritus, and acute and chronic pain.1 Eighty patients with hip osteoarthritis (OA) or knee OA were randomized to receive treatment with 0.25 mg, 0.5 mg, 1.0 mg or 5.0 mg CR845 twice daily for two weeks. Safety assessment, pharmacokinetics…
Bowing to Pressure, FDA to Reform Painkiller Approval Process
WASHINGTON (Reuters)—Bowing to pressure from lawmakers, Dr. Robert Califf, President Barack Obama’s nominee to lead the U.S. Food and Drug Administration (FDA), said on Thursday the agency would reform its process for approving opioid painkillers. Last month, Sen. Edward Markey (D-Ma.) placed a hold on Califf’s nomination, preventing it from being voted on by the…
California Doctor Gets 30 Years to Life in Landmark Overdose Case
LOS ANGELES (Reuters)—A Southern California doctor was sentenced to 30 years to life in prison on Friday for over-prescribing drugs that caused the fatal overdose of three patients in a murder case capped by the first conviction of its kind in the U.S. The case against Dr. Hsiu Ying “Lisa” Tseng, 46, comes amid what…
U.S. Appeals Court Ruling May Clear Barrier to Generic OxyContin
(Reuters)—A federal appeals court ruled Monday that four patents related to Purdue Pharma’s painkiller OxyContin are invalid, potentially bringing Teva Pharmaceutical Industries Ltd and others a step closer to introducing generic versions of the drug. Privately owned, Connecticut-based Purdue had sued Teva, Amneal Pharmaceuticals and Epic Pharma after they sought approval from the U.S. Food…
U.S. Sen. Markey Places Hold on Obama’s Nominee to Lead FDA
(Reuters)—U.S. Sen. Edward Markey (D-Mass.) said on Monday he has placed a hold on President Barack Obama’s nominee to head the U.S. Food and Drug Administration until the agency agrees to reform its process for approving opioid painkillers. Markey wants future opioid-approval matters to be reviewed by an FDA advisory committee, and believes the committee…
Opioid Investigated to Treat Acute & Chronic OA Pain; Plus New RA Treatment & More
In Phase 2 trials, the oral opioid, CR845, has proved promising in treating pain in patients with hip and knee osteoarthritis. Olokizumab is being investigated to treat RA, and in Canada, adalimumab has been approved to treat polyarticular JIA in 2–4 year-olds…
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