Journal
EXPERT OPINION ON PHARMACOTHERAPY
Volume 9, Issue 15, Pages 2717-2726Publisher
TAYLOR & FRANCIS LTD
DOI: 10.1517/14656566.9.15.2717
Keywords
angiogenesis; chronic wounds; diabetic foot ulcers; endothelial dysfunction; fracture repair; osteoporosis; rusalatide acetate
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Rusalatide acetate (Chrysalin (R)) is an investigational drug being evaluated for treatment of chronic wounds and fractures. Rusalatide acetate interacts with cell surface receptors to stimulate a cascade of cellular and molecular wound healing events, including activation of nitric oxide signaling. Rusalatide acetate significantly accelerated healing of diabetic foot ulcers and distal radius fractures in Phase I/II clinical trials. Subsequently, in one of the largest Phase III fracture studies to date, rusalatide acetate showed significant acceleration of distal radius fracture healing radiographically but failed to meet its primary clinical endpoint - time to removal of immobilization - within the intent-to-treat population. Subset analysis showed that rusalatide acetate met this primary clinical endpoint and significantly accelerated radiographic healing in osteopenic women. Rusalatide acetate may therefore show its greatest efficacy in healing-impaired patients.
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