Laser therapy technology company Erchonia Corporation reported on Wednesday the receipt of the US Food and Drug Administration's (FDA) 510(k) clearance to market its FX 635 low level laser for the temporary relief of chronic, nociceptive musculoskeletal pain.
The FDA clearance was based on the results from the company's double-blind and placebo-controlled clinical trials with 255 patients. Those treated with the FX 635 documented a 49% average pain reduction post treatment protocol. No other therapies were used in conjunction with the laser treatment.
Concurrently, the SPACE randomised clinical trial published in JAMA 2018 compared using opioids and non-opioids to treat overall chronic musculoskeletal pain. In the study, 119 patients were treated with opioids and 119 patients were treated with non-opioids. At three months, results showed a reduction in pain of only 20% with opioids and 26% with non-opioids, mainly NSAIDS. This study implemented many adjunctive therapies including exercise, physical therapy and chiropractic care.
In addition, the FDA's market clearance was based on the company's prior Level 1 blinded and controlled clinical trials on chronic neck and shoulder pain in 2002, plantar fasciitis, or heel pain, in 2014 as well as low back pain in 2018.
AbbVie's ELAHERE receives full US FDA approval
Johnson & Johnson's OPSYNVI receives US FDA approval
Outlook Therapeutics receives positive CHMP opinion for ONS-5010 in wet AMD treatment
Human Immunology Biosciences receives ODD from FDA for felzartamab
Eton Pharmaceuticals acquires PKU GOLIKE, expanding rare disease portfolio
Vertex receives FDA clearance for VX-407 Investigational New Drug Application for ADPKD
Phanes Therapeutics receives FDA Fast Track designation for PT886
Bio-Thera Solutions signs new licensing agreement with SteinCares
FDA accepts resubmission of Citius Pharmaceuticals, Inc's BLA for LYMPHIR
GSK Plc reports positive Phase III Jemperli data for endometrial cancer
ImmVira receives FDA Fast Track designation for MVR-T3011 IT