The FDA has expanded the indication of the over-the-counter pain reliever ActiPatch (BioElectronics Corp.) to include all musculoskeletal pain. Learn more about this and other recent drug approvals in this news brief.
The U.S. Food and Drug Administration (FDA) has expanded the indication of the over-the-counter pain reliever ActiPatch (BioElectronics Corp.) to include all musculoskeletal pain. Currently, ActiPatch, which is a pulsed shortwave therapy, is recommended for the treatment of pain from knee osteoarthritis and plantar fasciitis.
In a clinical trial published online in Future Medicine on May 29, 2019, of 174 patients with chronic pain who were treated with ActiPatch for seven days, all patients experienced pain relief by an average of 4.3 visual analog scale points. The company received 510(k) clearance from the FDA earlier this month.
Also, in February, the FDA approved the topical gel Voltaren Gel (diclofenac sodium topical gel 1%, GSK) as an over-the-counter pain reliever for the temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle or knee in adults. The treatment is currently available as a prescription only.
“Osteoarthritis treatment guidelines from several international and United States medical societies, including the 2019 American College of Rheumatology (ACR) endorse the early use of topical NSAIDs for treating arthritis pain of the knee and hand. In contrast to prior guidelines, the recommendations are inclusive of all age groups, not just the elderly,” said Roy Altman, M.D., of UCLA, in a GSK press statement.
In December, the TNF inhibitor and biosimilar to Remicade, infliximab-axxq (Avsola, Amgen Inc.), was approved for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Clinical trials of Avsola showed that it was highly similar to Remicade with no clinically meaningful differences in patients with moderate-to-severe rheumatoid arthritis.