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Testosterone Effective In Female Sexual Dysfunction
according to new study
Nov. 13, 2008. BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX),
a specialty
pharmaceutical company focused on developing products for
female sexual health,
menopause, contraception, and male hypogonadism, commented
today on a new
publication reporting on the efficacy of testosterone in the
treatment of Female Sexual
Dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD)
in menopausal
women. In a paper titled, "Testosterone for Low Libido in Postmenopausal Women Not
Taking Estrogen," the authors state that
testosterone therapy provides modest but
meaningful benefit in the
treatment of HSDD in postmenopausal women and that as
reported in previous blinded
studies, 85 percent of those women reporting a benefit wish to
continue treatment. The authors
also state that, "Additional data are needed to assess the
long-term safety of
testosterone in women with estrogen depletion." The paper appeared in
the November 6,
2008, issue of the New England Journal of Medicine.
BioSante currently has two Phase III clinical trials in
progress covered by an SPA (Special
Protocol Assessment) with the FDA, to demonstrate
the safety and efficacy of LibiGel
(testosterone gel), in the treatment of HSDD. In addition to
the two LibiGel Phase III safety
and efficacy trials, BioSante is enrolling women in a
Phase III cardiovascular and breast
cancer safety study of LibiGel. Pursuant to a
written agreement with the FDA, this one
safety study will serve as the basis of
safety for both surgically and naturally menopausal
women. The safety study is a
randomized, double- blind, placebo-controlled, multi-center,
cardiovascular events driven
study of between 2,400 and 3,100 women exposed to LibiGel
or placebo for twelve months. At
the end of the twelve months, BioSante intends to submit
a LibiGel New Drug
Application (NDA) for review and possible approval by the FDA.
BioSante will continue
to follow the women enrolled in the safety study for an additional
four years after
the NDA submission and possible approval of LibiGel.
BioSante holds two SPAs for LibiGel for the treatment of FSD;
one for "surgically" and one
for "naturally" menopausal women. "BioSante's SPAs
confirm the FDA's position that FSD
and HSDD are true diagnosable conditions
that women experience, with measurable
endpoints that can be evaluated and which deserve
therapeutic options. Regarding LibiGel
specifically, we are pleased that the SPAs
affirm that our clinical trial design, endpoints,
sample size, planned conduct and
statistical analyses are acceptable to support regulatory
approval," said Stephen M. Simes,
BioSante's president & CEO. "We have a clearly
defined, reasonable and feasible LibiGel development path that can lead to the approval of
LibiGel to provide
potential benefit for a broad population of menopausal women."
"No pharmaceutical product is approved for the treatment of
FSD or HSDD in the U.S.
LibiGel, if approved by the FDA, will address a truly
unserved medical need. BioSante
today is the only company actively in development of
a product for the treatment of FSD in
menopausal women and is the only company
that has initiated a long-term safety study to
determine the safety of
testosterone in this indication. BioSante is committed to the
development of LibiGel, which
ultimately could be the first prescription pharmaceutical
product approved by the FDA
for this treatment in the U.S." Although Procter & Gamble
has conducted several
clinical trials of its Intrinsa testosterone patch, P & G has not initiated
a long-term safety
study which is a critical FDA requirement for possible approval of a
testosterone product for the treatment of FSD.
As previously announced by BioSante, treatment with LibiGel
in a Phase II clinical trial
significantly increased satisfying sexual events in
surgically menopausal women suffering
from FSD. The Phase II trial results showed LibiGel
significantly increased the number of
satisfying sexual events by 238 percent versus baseline
(p<0.0001); this increase also was
significant versus placebo (p<0.05). In this study, the
effective dose of LibiGel produced
testosterone blood levels within the normal range for
pre- menopausal women and had a
safety profile similar to that observed in the
placebo group. In addition, no serious adverse
events and no discontinuations due
to adverse events occurred in any subject receiving
LibiGel. The Phase II clinical
trial was a double-blind, placebo-controlled trial, conducted
in the United States, in
surgically menopausal women distressed by their low sexual desire
and activity.
About LibiGel®
LibiGel is a gel formulation of testosterone designed to be
quickly absorbed through the
skin after application of a pea-sized dose of gel on the upper arm,
delivering testosterone to
the bloodstream evenly over time and in a non-invasive and
painless manner. Though
generally characterized as a male hormone, testosterone
also is present in women and its
deficiency has been found to decrease libido or
sex drive. In addition, studies have shown
that testosterone therapy can increase bone
density, raise energy levels and improve mood,
in addition to boosting sexual desire and
activity.
According to a study published in the Journal of the American
Medical Association,
43
percent of American women (about 40 million) experience some degree of impaired sexual
function. Among the more than 1,400 women surveyed, 32
percent lacked interest in sex
and 26 percent could not experience orgasm.
According to IMS data, 2.0 million
testosterone prescriptions were written off-label for
women by U.S. physicians in 2007.
The majority of women with FSD are postmenopausal, experiencing FSD due to hormonal
changes following menopause, whether
natural or surgical.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on
developing products for female
sexual health, menopause, contraception and male hypogonadism. BioSante's lead products
include LibiGel® (transdermal testosterone gel)
in Phase III clinical development by
BioSante under a U.S. Food and
Drug Administration (FDA) SPA (Special Protocol
Assessment) for the treatment of
female sexual dysfunction (FSD), and Elestrin™ (estradiol
gel) developed
through FDA approval by BioSante, indicated for the treatment of
moderate-to-severe vasomotor
symptoms associated with menopause, currently marketed
in the U.S. Also in
development are Bio-T-Gel™, a testosterone gel for male
hypogonadism, and an oral
contraceptive in Phase II clinical development using BioSante
patented technology. The
current market in the U.S. for estrogen and testosterone products
is approximately $2.5
billion and for oral contraceptives approximately $3 billion. The
company also is
developing its calcium phosphate technology (CaP) for novel vaccines,
drug delivery and
aesthetic medicine (BioLook™). Additional information is available online
at: http://www.biosantepharma.com.
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