After meeting with the FDA, the makers of intravenous meloxicam plan to resubmit the treatment’s new drug application…
FDA Expands Safety Measures for Immediate Release Opioids
The FDA has expanded the new Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) to include immediate release opioids. The program, which also includes extended release and long acting opioids, will provide education to prescribers and healthcare professionals…
The FDA Denies Approval for Remoxy Extended Release; Plus Knee OA Pain Treatment Moves into Phase 3 Trials
The FDA has not approved extended release Remoxy, a gel capsule formulation of oxycodone, concluding that its potential benefits do not outweigh its risks…
EU Grants Marketing Authorization for Hyrimoz; Plus FDA Rejects New Drug Application for Buprenorphine Sublingual Spray
In late July, the European Commission granted marketing approval for Hyrimoz, which is biosimilar to adalimumab…
A Comprehensive Review of NSAID Cardiovascular Toxicity
Non-steroidal anti-inflammatory drugs (NSAIDs) are the most used drugs for acute and chronic pain. More than 30 billion doses of NSAIDs are consumed annually from more than 70 million prescriptions.1 Despite their common use, NSAIDs are not free of serious toxicities. In the pre-Vioxx (rofecoxib) era, gastrointestinal toxicity was the primary concern for many NSAIDs….
FDA Approves Combination Therapy for OA Pain, but Not Duobrii Lotion for Plaque Psoriasis
The FDA has approved a combination of amlodipine and celecoxib, which may lower serum creatinine, for treating osteoarthritis pain and hypertension…
IV Tramadol Promising for Postoperative Pain; FDA Denies IV Meloxicam Approval
In its first phase 3 clinical trial, intravenous tramadol has met its primary endpoint for relieving postoperative pain…
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 to Review Abuse Deterrent Oxycodone Capsule & More
The FDA will discuss a New Drug Application for Remoxy ER during an upcoming advisory committee meeting and recently approved tildrakizumab-asmn to treat adults with plaque psoriasis…
Study Examines Why Patients Exceed Recommended Doses of Ibuprofen & NSAIDs
A recent study examined how often patients exceed the dosing limits of nonsteroidal anti-inflammatory drugs and identified the characteristics of the patients most likely to exceed recommended doses…
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