Revance: Botulinum Toxin for Plantar Fasciitis
Elizabeth Hofheinz, M.P.H., M.Ed. • Mon, November 14th, 2016
Revance Therapeutics, Inc. has announced the initiation of a Phase 2 placebo-controlled trial of its investigational drug candidate DaxibotulinumtoxinA for Injection (RT002) for the management of plantar fasciitis. According to the November 3, 2016 news release, the study is expected to enroll approximately 60 patients in the U.S. who will be followed for 16 weeks. The study’s primary efficacy endpoint is the improvement in the American Orthopaedic Foot and Ankle Society Score (AOFAS).
“The plantar fascia is the foot’s shock absorber. Repeated pressure on this tissue, whether from sport activities, aging, or obesity, can create small tears in or overstretch the fascia. The result is inflammation accompanied by sharp, constant pain that often gets worse over time and can become highly debilitating, " said Clinical Investigator L. Andrew Koman, M.D., professor and chair of the Department of Orthopaedic Surgery and executive director Musculoskeletal Service Line, Wake Forest School of Medicine. “Preclinical and clinical research suggests a neurotoxin candidate such as RT002 may provide patients with sustained relief from chronic heel pain and support healing of the plantar fascia without the risks of plantar fascia rupture or atrophy of the fat pad that can occur with corticosteroid injections.”
“This Phase 2 study for plantar fasciitis will advance a whole new treatment area for botulinum toxin that addresses pain and muscle tightness. Revance has the opportunity to be a first mover for this indication and other musculoskeletal disorders, ” said Dan Browne, president and chief executive officer at Revance. “No botulinum toxin is approved for treating plantar fasciitis; however, the clinical endpoints are well validated. Published estimates place the annual U.S. evaluation and treatment market for plantar fasciitis at more than $250 million, and we believe the market could grow significantly larger if patients had a compelling neurotoxin treatment option.”
Dr. Koman told OTW, “Plantar fasciitis involves pain and inflammation of the plantar fascia; concomitant tightness of the plantar foot and heel cord contribute. Botulinum toxin has unique properties of targeted decrease in pain combined with relaxation of the contracted structures addressing the cause and effect simultaneously.”
“This modality provides an improved alternative to steroids without heel pad atrophy and will relieve symptoms and treat the causal process without shock wave therapy or surgery.”