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news.TransPharma Medical has reported positive results from a Phase I study evaluating ViaDerm-Calcitonin, its self-applied transdermal Calcitonin product for the treatment of musculoskeletal disorders such as osteoarthritis and musculoskeletal pain.
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Calcitonin is a drug indicated for the treatment of postmenopausal osteoporosis, hypercalcemia, and Paget’s disease, and is commercially available in subcutaneous, intramuscular and nasal routes.
The open-label, single-dose, cross-over, Phase I study was designed to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of ViaDerm-Calcitonin in postmenopausal women, compared to Miacalcin – the subcutaneous injected form of the Calcitonin.
The study enrolled 12 postmenopausal women, who were treated with four different transdermal Calcitonin doses (60-300 mcg) or 100IU of Miacalcin.
The study results demonstrated a clear PK dose response relative to the escalating doses of the ViaDerm-Calcitonin patches.
In addition, a single administration of ViaDerm-Calcitonin lead to a statistically significant reduction of bone resorption and cartilage degradation biomarkers, CTX-I and CTX-II, similar to the reduction observed with daily injections of 100 IU Miacalcin.
All doses of ViaDerm-Calcitonin were safe and well-tolerated, and showed a favorable profile with respect to skin safety.