ViaDerm-Calcitonin is designed to treat musculoskeletal disorders such as osteoarthritis and musculoskeletal pain.
A phase I clinical trial of a self-applied ViaDerm-Calcitonin product for the treatment of musculoskeletal disorders such as osteoarthritis and musculoskeletal pain, reveals positive results.
The study demonstrated that a single administration of ViaDerm-Calcitonin resulted in a statistically significant reduction of bone resorption and cartilage degradation biomarkers, CTX-I and CTX-II, similar to the reduction obtained with daily injections of 100 IU Miacalcin.
The product is manufactured by TransPharma Medical Ltd., a specialty pharmaceutical company. The company is focused on developing and commercializing drug products that utilize a proprietary active transdermal drug delivery technology.
TransPharma's ViaDerm drug delivery system incorporates a handheld electronic device, which creates microscopic passageways through the outer layer of the skin allowing for transdermal delivery of a wide variety of drugs from a patch. The system may provide a cost-effective, easy-to-use, virtually pain-free, self-administered solution.
The phase I study of ViaDerm-Calcitonin was an open label single dose cross-over trial to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ViaDerm-Calcitonin in 12 postmenopausal women treated with four different transdermal Calcitonin doses (60-300 mcg) compared to 100IU of Miacalcin, the subcutaneous injected form of the Calcitonin.
All doses of ViaDerm-Calcitonin were safe and well-tolerated and demonstrated a favorable profile with regard to skin safety.
Calcitonin is commercially available in subcutaneous, intramuscular, and nasal routes for the treatment of postmenopausal osteoporosis, hypercalcemia, and Paget's disease. Calcitonin has been widely used for many years and is currently being assayed for the treatment of osteoarthritis and various musculoskeletal clinical painful conditions.
"We are very pleased with the results of this study, which demonstrate that our transdermal Calcitonin is safe and as efficacious as a subcutaneous injection," said Dr. Daphna Heffetz, CEO of TransPharma Medical, in a press release. "It leads us to believe that enhancing these capabilities with the ease of use, virtual painlessness, small size and portability of our ViaDerm system may open up a myriad of possibilities to expand the therapeutic applications of Calcitonin beyond the current approved indications."
Source: TransPharma Medical
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