(Reuters)—A U.S. Food and Drug Administration (FDA) advisory panel recommended approving Teva Pharmaceuticals Industries Ltd’s long-acting opioid painkiller, Vantrela ER, saying data showed it reduces pain and has some abuse-resistant properties. The drug is designed for use every 12 hours for the management of pain severe enough to require around-the-clock treatment in patients who have…

FDA Restricts Use of Systemic Fluoroquinolones Due to Side Effects & Will Review Application of Apadaz for Pain
The FDA has issued new safety guidelines for systemic fluoroquinolones, restricting their use to patients with no alternative treatment options…
Lilly Says New Type of Pain Drug Could Reduce Need for Opioids
(Reuters)—Eli Lilly and Co. on Tuesday said it and partner Pfizer Inc. aim to seek approval by 2018 for a new type of pain drug that could be an alternative to opioids for osteoarthritis, chronic back pain and cancer pain. The Indianapolis drugmaker said tanezumab, given by injection every eight weeks, could be a far…
U.S. FDA Approves First-Ever Implant to Treat Opioid Addiction
(Reuters)—The first-ever implant to fight addiction to opioids, a class of drugs that includes prescription painkillers and heroin, was approved by the U.S. Food and Drug Administration on Thursday. The matchstick-sized implant, developed by Titan Pharmaceuticals Inc. and privately owned Braeburn Pharmaceuticals, is by design less susceptible to abuse or the illicit resale that plagues…
Regeneron Pain Drug Clears Late-Stage Trial
(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…
- « Previous Page
- 1
- …
- 9
- 10
- 11
- 12
- 13
- …
- 15
- Next Page »