Daré Bioscience, Inc. (NASDAQ: DARE), a leader in
innovation for the health and wellbeing of women, today announced
the publication in Obstetrics & Gynecology, the official
publication of the American College of Obstetricians and
Gynecologists (ACOG), of the Phase 2b study efficacy results of
topical Sildenafil Cream 3.6% (Sildenafil Cream), which is being
developed for the treatment of female sexual arousal disorder
(FSAD).
The Phase 2b clinical study was designed as an exploratory,
multi-center, double-blind, placebo-controlled study to evaluate
the preliminary efficacy and safety of Sildenafil Cream, 3.6% in
premenopausal patients with FSAD. Topical Sildenafil Cream improved
outcomes among women with FSAD, most significantly in a subset of
women both with and without concomitant decreased desire. In an
exploratory post-hoc analysis of this group, topical Sildenafil
Cream significantly increased sexual arousal sensation and reduced
sexual distress, as well as improved desire and orgasm.
“Arousal disorder represents a significant unmet need, impacting
approximately 20% of women in the U.S.¹,” said Dr. Annie Thurman,
MD, FACOG, Medical Director at Daré Bioscience. “Publication of
this efficacy manuscript in an important peer-reviewed medical
journal validates the importance of these findings for the field,
shedding light for the first time on which women with FSAD and
symptoms can be expected to benefit most from the increased genital
blood flow that Sildenafil Cream mechanistically provides, and
further underscores the potential of Sildenafil Cream to address
the unmet need and improve outcomes for women with FSAD.”
“We are so pleased that this manuscript has been accepted in the
official publication of the American College of Obstetricians and
Gynecologists,” added Sabrina Martucci Johnson, President and CEO
of Daré Bioscience. “It truly underscores the importance of these
groundbreaking data and can hopefully continue to advance the field
with the insights these data provide into this patient population
as well as the patient reported outcome measures that are most
meaningful to them in measuring their improvement.”
Daré Bioscience previously announced a positive end-of-Phase 2
meeting with the U.S. Food and Drug Administration (FDA) supporting
advancement of Sildenafil Cream for the treatment of FSAD and has
continued to interact with the FDA as the FDA reviews,
specifically, the data generated on the proposed endpoints to take
forward into Phase 3 development. The FDA has indicated that it
aims to complete its review of the Phase 2b study data and provide
comments this quarter on the proposed primary and secondary patient
reported outcome endpoints for the planned Phase 3 pivotal trials
of Sildenafil Cream to support potential product registration and
labeling.
The in-press accepted manuscript, entitled “Preliminary
Efficacy of Topical Sildenafil Cream for the Treatment of Female
Sexual Arousal Disorder: A Randomized Controlled Trial” is
available online
at https://journals.lww.com/greenjournal/fulltext/9900/preliminary_efficacy_of_topical_sildenafil_cream.1101.aspx.
About FSAD and Sildenafil Cream, 3.6%
FSAD, as described in the DSM-IV, is a condition characterized
as primarily by a persistent or recurrent inability to attain or
maintain sufficient genital arousal (an adequate
lubrication-swelling response) during sexual activity, frequently
resulting in distress or interpersonal difficulty, and, of the
various types of female sexual dysfunction disorders, FSAD is
clinically analogous to erectile dysfunction (ED) in men. As with
ED in men, FSAD is associated with insufficient blood flow to the
genitalia.
Sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, is the
active ingredient in a tablet for oral administration currently
marketed under the brand name Viagra® for the treatment of ED in
men. Sildenafil Cream is an investigational, proprietary cream
formulation of sildenafil designed for topical administration to
the vulvar-vaginal tissue on demand to increase genital blood flow
and provide improvements in the female genital arousal response,
while avoiding systemic side effects observed with oral
formulations of sildenafil.
Market research suggests that 16% of women in
the U.S. ages 21 to 60, or approximately 10 million
women, are distressed from experiencing symptoms associated with
FSAD, including lack of or low sexual arousal, and are actively
seeking solutions to improve their condition. In comparison, the
prevalence of complete ED in men is estimated to be about 5% of men
at age 40, increasing to about 15% at age 70.
About Daré Bioscience
Daré Bioscience is a biopharmaceutical company committed to
advancing innovative products for women’s health. The company’s
mission is to identify, develop and bring to market a diverse
portfolio of differentiated therapies that prioritize women's
health and well-being, expand treatment options, and improve
outcomes, primarily in the areas of contraception, vaginal health,
reproductive health, menopause, sexual health and fertility.
The first FDA-approved product to emerge from Daré’s portfolio
of women’s health product candidates is XACIATO™ (clindamycin
phosphate) vaginal gel 2%, a lincosamide antibacterial indicated
for the treatment of bacterial vaginosis in female patients 12
years of age and older, which is under a global license agreement
with Organon. Organon commenced U.S. marketing of XACIATO in the
fourth quarter of 2023. Daré’s portfolio also includes potential
first-in-category candidates in clinical development: Ovaprene®, a
novel, hormone-free monthly intravaginal contraceptive
whose U.S. commercial rights are under a license
agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream
formulation of sildenafil, the active ingredient in Viagra®, to
treat female sexual arousal disorder (FSAD); and DARE-HRT1, a
combination bio-identical estradiol and progesterone intravaginal
ring for menopausal hormone therapy. To learn more about XACIATO,
Daré’s full portfolio of women’s health product candidates, and
Daré’s mission to deliver differentiated therapies for women,
please visit www.darebioscience.com.
Daré Bioscience leadership has been named on the Medicine
Maker’s Power List and Endpoints News’ Women
in Biopharma 2022. In 2023, Daré's CEO was honored as one
of Fierce Pharma’s Most Influential People
in Biopharma for Daré’s contributions to innovation and
advocacy in the women’s health space. Daré Bioscience placed #1 in
the Small Company category of the San Diego Business
Journal’s 2023 Best Places to Work Awards.
Daré may announce material information about its finances,
product and product candidates, clinical trials and other matters
using the Investors section of its website
(http://ir.darebioscience.com), SEC filings, press
releases, public conference calls and webcasts. Daré will use these
channels to distribute material information about the company and
may also use social media to communicate important information
about the company, its finances, product and product candidates,
clinical trials and other matters. The information Daré posts on
its investor relations website or through social media channels may
be deemed to be material information. Daré encourages investors,
the media, and others interested in the company to review the
information Daré posts in the Investors section of its website and
to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and
@DareBioscience. Any updates to the list of social media channels
the company may use to communicate information will be posted in
the Investors section of Daré’s website.
Forward-Looking Statements
Daré cautions you that all statements, other than statements of
historical facts, contained in this press release, are
forward-looking statements. Forward-looking statements, in some
cases, can be identified by terms such as “believe,” “may,” “will,”
“estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,”
“could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,”
“contemplate,” “project,” “target,” “objective,” or the negative
version of these words and similar expressions. In this press
release, forward-looking statements include, but are not limited
to, statements relating to Sildenafil Cream’s potential as a safe
and effective therapy for FSAD, Daré’s plans for continued clinical
development of Sildenafil Cream, the timing of FDA comments on
Sildenafil Cream Phase 3 clinical study design, the potential for
Sildenafil Cream to be the first FDA-approved treatment of FSAD,
and the potential market opportunity for Sildenafil Cream.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause Daré’s actual
results, performance or achievements to be materially different
from future results, performance or achievements expressed or
implied by the forward-looking statements in this press release,
including, without limitation, risks and uncertainties related to:
Daré’s ability to raise additional capital when and as needed to
advance its product candidates, execute its business strategy and
continue as a going concern; the risk that data from the Phase 2b
study may not be predictive of positive results of any future
clinical study; the risk that the FDA, other regulatory
authorities, members of the scientific or medical communities or
investors may not accept or agree with Daré’s interpretation of or
conclusions regarding the study data; the risk that positive
findings in early clinical and/or nonclinical studies of a product
candidate may not be predictive of success in subsequent clinical
and/or nonclinical studies of that candidate; the risk that
development of a product candidate requires more clinical or
nonclinical studies than Daré anticipates; Daré’s ability to
develop, obtain FDA or foreign regulatory approval for, and
commercialize its product candidates and to do so on communicated
timelines; failure or delay in starting, conducting and completing
clinical trials of a product candidate; Daré’s ability to design
and conduct successful clinical trials, to enroll a sufficient
number of patients, to meet established clinical endpoints, to
avoid undesirable side effects and other safety concerns, and to
demonstrate sufficient safety and efficacy of its product
candidates; Daré’s dependence on third parties to conduct clinical
trials and manufacture and supply clinical trial material and
commercial product; the loss of, or inability to attract, key
personnel; the effects of macroeconomic conditions, geopolitical
events, public health emergencies, and major disruptions in
government operations on Daré’s operations, financial results and
condition, and ability to achieve current plans and objectives; the
impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; the
risk that developments by competitors make Daré’s product or
product candidates less competitive or obsolete; difficulties
establishing and sustaining relationships with development and/or
commercial collaborators; failure of Daré’s product or product
candidates, if approved, to gain market acceptance or obtain
adequate coverage or reimbursement from third-party payers; Daré’s
ability to retain its licensed rights to develop and commercialize
a product or product candidate; Daré’s ability to satisfy the
monetary obligations and other requirements in connection with its
exclusive, in-license agreements covering the critical patents and
related intellectual property related to its product and product
candidates; Daré’s ability to adequately protect or enforce its, or
its licensor’s, intellectual property rights; the lack of patent
protection for the active ingredients in certain of Daré’s product
candidates which could expose its products to competition from
other formulations using the same active ingredients; product
liability claims; governmental investigations or actions relating
to Daré’s product or product candidates or the business activities
of Daré, its commercial collaborators or other third parties on
which Daré relies; the impact of pharmaceutical industry regulation
and health care legislation in the United States and
internationally; global trends toward health care cost containment;
cybersecurity incidents or similar events that compromise Daré’s
technology systems or those of third parties on which it relies
and/or significantly disrupt Daré’s business; and disputes or other
developments concerning Daré’s intellectual property rights. Daré’s
forward-looking statements are based upon its current expectations
and involve assumptions that may never materialize or may prove to
be incorrect. All forward-looking statements are expressly
qualified in their entirety by these cautionary statements. For a
detailed description of Daré’s risks and uncertainties, you are
encouraged to review its documents filed with
the SEC including Daré’s recent filings on Form 8-K, Form
10-K and Form 10-Q. You are cautioned not to place undue
reliance on forward-looking statements, which speak only as of the
date on which they were made. Daré undertakes no obligation to
update such statements to reflect events that occur or
circumstances that exist after the date on which they were made,
except as required by law.
Contacts:
Media and Investors on behalf of Daré Bioscience,
Inc:Camilla White / Simona KormanikovaDentons Global
AdvisorsDareBioscience@dentonsglobaladvisors.com /
1.212.466.6450
Source: Daré Bioscience, Inc.
____________________________________¹ Laumann EO, Michael RT and
Gagnon JH. A political history of the national sex survey of
adults. Fam Plann Perspect 1994; 26: 34-38.Witherow-Parkanyi M.
Female sexual interest/arousal disorder: history of diagnostic
considerations and their implications for clinical practice.
Psychiatr Hung 2022; 37: 133-149.Jayne C and Gago BA. Diagnosis and
treatment of female sexual arousal disorder. Clin Obstet Gynecol
2009; 52: 675-681. DOI: 10.1097/GRF.0b013e3181bf4982.
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