New prescribing guidance has been issued by the FDA for immediate-release and extended-release/long-acting opioids for pain management. The agency also announced multiple label updates, which include changes to the Boxed Warnings.
FDA Advisory Committees Reject Oxycodegol (NKTR-181) Application
FDA advisory committees rejected the new drug application for oxycodegol, an opioid analgesic, due to a lack of data regarding it’s potential for abuse…
Opioids Commonly Prescribed for Gout Attacks
NEW YORK (Reuters Health)—Nearly three in 10 patients seeking care at the emergency department (ED) for acute gout will be discharged with a prescription for opioids, new research shows. “Our study suggests a high use of prescription opioid in patients discharged from the ED with a diagnosis of gout, a condition that can be managed…
Clinicians’ Use of ‘Safer’ Opioid-Prescribing Practices Spotty
NEW YORK (Reuters Health)—Many U.S. clinicians aren’t following risk-mitigation practices for opioid prescribing, new findings show. “In response to this national opioid crisis, consensus-based safer opioid prescribing guidelines have been published and state laws regulating opioid prescribing practices have been enacted,” Daniel P. Alford, MD, of Boston University School of Medicine, and colleagues write in…
Canada Approves Erelzi for PsA; Plus FDA Moves to Increase Access to Naloxone
Health Canada has approved Erelzi, which is biosimilar to Enbrel (etanercept), for treating psoriatic arthritis in adults…
FDA Approves Opioid Treatment
The FDA has approved the use of sublingual sufentanil (Dsuvia) to treat acute pain in adults in a medically supervised setting…
Nonopioid Medication May Be as Effective as Opioids for Chronic Pain
A recent study compared the efficacy of opioids with nonopioid pain treatments in patients with chronic back pain and hip or knee osteoarthritis. After 12 months, researchers found that treatment with opioids was not superior to treatment with nonopioid medication, with only minor differences in patients’ functional responses to the medications…
FDA Sets Stricter Requirements for Immediate-Release Opioids to Prevent Misuse & Abuse
The FDA is expanding its Risk Evaluation and Mitigation Strategy (REMS) to include manufacturers of immediate-release opioids. The makers of these drugs will soon be required to provide training and education to healthcare professionals on the proper prescription and use of the drugs for pain management…
Rheumatology Drug Updates: Opana ER Painkiller Pulled from U.S. Market; Upadacitinib to Treat RA, and More
Opana ER Pulled from U.S. Market Last month, the U.S. Food and Drug Administration (FDA) asked Endo Pharmaceuticals to remove oxymorphone hydrochloride extended release (Opana ER) from the U.S. market due to public health consequences related to abuse. The agency has concerns that the risks presented by the treatment do not outweigh its benefits.1 On…
CVS to Pay $5 Million to Resolve U.S. Drug Probe
(Reuters)—CVS Health Corp. has paid $5 million to resolve allegations that pharmacies it operates in California failed to keep and maintain accurate records of prescription drugs, the U.S. Justice Department said on Tuesday. The deal follows an investigation that began in 2012 after the U.S. Drug Enforcement Administration noticed an increased number of thefts and unexplained…