Home » Drug Information » Recently Approved Drugs » 1995
Medical Areas: Endocrinology | Musculoskeletal | Obstetrics/Gynecology
Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Sandoz Pharmaceuticals
Approval Status: Approved on August 17, 1995
Treatment Area: post-menopausal osteoporosis
Miacalcin Nasal Spray (MNS) is a synthetic form of the hormone
calcitonin, which inhibits bone loss. Previously available only in
injectable form, Miacalcin is now available in a nasal spray.
Miacalcin is indicated for the treatment of postmenopausal
osteoporosis in women who are more than five years past menopause
and who have low bone mass compared with women before menopause.
MNS is recommended for women who refuse or cannot tolerate
estrogens or in whom estrogens should not be used. MNS should be
taken with adequate calcium (at least 1000 mg elemental calcium per
day) and vitamin D (400 international units) per day.
The medication has been used by thousands of women in 72
countries outside the U.S.
Evidence of efficacy is based on increases in spinal bone
mineral density observed in 551 postmenopausal women with
osteoporosis who were studied for up to two years.
Nasal irritation and other symptoms of the nose such as dryness,
redness, itching, or bleeding were the most commonly reported side
effects.
Miacalcin nasal spray, like natural calcitonin, acts primarily
by inhibiting osteoclasts, the cells that break down existing bone,
thereby decreasing the rate of bone breakdown, allowing the body to
build bone naturally.