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• actonel • aredia • boniva • didronel • evista • Forteo • fosamax • miacalcin • zometa • vivelle • reclast •
NEW YORK (Reuters) - Noven
Pharmaceuticals Inc. said Friday that its
treatment for menopausal symptoms, Vivelle, has
been additionally approved by U.S. regulators to
address postmenopausal osteoporosis.
The company said Vivelle, which has been on the
market to address the effects of menopause since
March 1996, has received U.S. Food and Drug
Administration approval to fight the bone
disease.
The product delivers estradiol, the primary
estrogen produced by the ovaries, through a
patch that is applied twice per week, the Miami,
Fla.-based company said. Four dosages of Vivelle
are currently available and the company said a
fifth, lower dosage was approved by the FDA for
the treatment of osteoporosis.
Doctors now have a new, effective treatment
option to help patients reduce their risk of
developing postmenopausal osteoporosis. The U.S.
Food and Drug Administration (FDA) has approved
an existing transdermal estrogen patch, marketed
by Novogyne Pharmaceuticals, a joint venture
between Noven Pharmaceuticals, Inc. and Novartis
Pharmaceuticals Corporation, for the prevention
of postmenopausal osteoporosis. The patch, sold
under the Vivelle brand name, has been available
for the treatment of menopausal symptoms since
March 1996.
Vivelle is available by prescription and
utilizes Noven's transdermal matrix technology.
The product delivers estradiol, the primary
estrogen produced by the ovaries, through a
patch that is applied twice weekly.
Vivelle is now indicated for the prevention of
osteoporosis and currently available in four
dosage strengths (0.0375, 0.05, 0.075 and 0.1
mg/day). A new low dose of Vivelle, 0.025
mg/day, is expected to be available in U.S.
pharmacies in late 2000. The 0.025 mg/day dosage
strength is about the size of a quarter.
After menopause, a woman can lose up to 20% of
her bone mass, making her more susceptible to
osteoporosis. In the U.S., 80 percent of those
suffering from osteoporosis are women. "Use of
hormone replacement therapies, such as Vivelle,
can help reduce the risk of osteoporosis and, at
the same time, help women experiencing menopause
ease menopausal symptoms such as hot flashes,
night sweats and vaginal dryness," said W. Neil
Jones, Executive Director Marketing and Sales
at Noven Pharmaceuticals, Inc.
In clinical trials, systemic adverse events with
Vivelle (estradiol transdermal system) and
placebo, respectively, include headache (36% vs.
30%), breast tenderness (4.9% vs. 1.1%), fluid
retention (3.8% vs. 2.2%) and back pain (13% vs.
4.5%). Local application site reactions with
Vivelle were approximately 9% vs. 10% in
patients treated with placebo; most cases were
considered mild, none were considered severe.
Estrogens should not be used in individuals with
known or suspected pregnancy, undiagnosed
abnormal genital bleeding, breast cancer,
estrogen- dependent neoplasia, active
thrombophlebitis or thromboembolic disorders, or
a documented history of these conditions.
Estrogens have been reported to increase the
risk of endometrial carcinoma in postmenopausal
women.
Vivelle is marketed by Novogyne Pharmaceuticals,
a joint venture between Novartis Pharmaceuticals
Corporation of East Hanover, New Jersey, and
Noven Pharmaceuticals, Inc. of Miami, Florida.
Vivelle Prescribing Information is available at
www.novogyne.com, or by calling (888) NOW-NOVA. |
