(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…
FDA Approves New Drugs for Pain
FDA Updates Belbuca, buccal-administered buprenorphine, has received U.S. Food and Drug Administration (FDA) approval for treating severe chronic pain.1 The dosage form is a dissolving film that is absorbed through the inner lining of the cheek for chronic pain management. It’s expected to be commercially available in the first quarter of 2016. Seven dosage strengths…
French ‘Cannabis’ Drug Trial Leaves 1 Brain Dead, 5 Injured
PARIS (Reuters)—One person has been left brain dead and five others are in a serious condition after taking part in a clinical trial in western France of an experimental medicine from an unnamed drug company, the French health ministry said on Friday, Jan. 15. The ministry did not say what the medicine was intended to be used…
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