Oral Calcitonin Tablet Safe for Treating Osteoporosis

(Ivanhoe Newswire) — OSTORA, a new oral drug made of salmon calcitonin, was in its third phase of study to determine if it effectively treated postmenopausal osteoporosis. The researchers deemed it safe and effective.
The ORACAL study was a Phase III multinational, randomized, double-blind, double-dummy, placebo-controlled trial of Tarsa’s oral recombinant salmon calcitonin compared to commercially available, synthetic salmon calcitonin administered by nasal spray and to placebo. The trial enrolled 565 postmenopausal women in six countries with established osteoporosis.
“These are encouraging results that may be of particular relevance for the women with osteoporosis who are reluctant to take or unable to tolerate currently available treatments,” Neil Binkley, MD, who is an Associate Professor of Endocrinology and Geriatrics at the University of Wisconsin School of Medicine and Public Health in Madison, Wisconsin, was quoted as saying. “Potential safety issues with current drug therapies, while rare, have led some osteoporosis patients to discontinue therapy or avoid beginning treatment. Calcitonin has a long history of safety for postmenopausal osteoporosis treatment, and potential availability of this once-daily oral formulation could make it a useful new option for osteoporosis patients and their physicians.”
According to the International Osteoporosis Foundation, studies indicate that up to half of osteoporosis patients stop their treatment after just one year. In one study, two-thirds of osteoporosis patients said their medication interfered with their lives in some way and over 20% of the women who missed or stopped their treatment said it was due to side effects.
Calcitonin is approved for the treatment of postmenopausal osteoporosis, but its use has been limited by the fact that it is currently available only in intranasal and injectable forms. Prior clinical studies show that Tarsa’s oral calcitonin tablet delivers calcitonin effectively and reduces blood levels of bone resorption biomarkers.
“We view the new OSTORA data presented today as very promising news for osteoporosis patients and their physicians seeking additional treatment options,” David Brand, President and CEO of Tarsa, was quoted as saying. “We look forward to filing a New Drug Application for OSTORA with the Food and Drug Administration and to submitting a Marketing Authorization Application to the European Medicines Agency thereafter. We also are advancing our ongoing Phase Il trial in osteoporosis prevention, an indication for which our oral calcitonin could be especially relevant.”
SOURCE: American Society for Bone and Mineral Research 2011 Annual Meeting by ORACAL held in San Diego California from September 2011