Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health
innovation, today announced the publication of results of the
patient-centered study designed to elucidate the commonly reported
symptoms, including severity of symptoms, associated with female
sexual arousal disorder (FSAD). The publication, “Symptoms and
associated impact in pre-and postmenopausal women with sexual
arousal disorder: a concept elicitation study,” appears in The
Journal of Sexual Medicine.
The concept elicitation study, also referred to as a content
validity study, to explore the experience of condition-associated
symptoms and the relative importance of FSAD symptoms, including
their severity, bother, and impact, on participants’ health-related
quality of life in pre- and postmenopausal women with FSAD was
completed prior to commencement of the exploratory Phase 2b RESPOND
clinical study of Sildenafil Cream, topline data for which are
anticipated during 2Q-2023. The non-interventional study was
conducted to identify and document the genital arousal symptoms
that are the most problematic and most important symptoms to treat
for women with FSAD. The findings of this content validity study
helped facilitate alignment with the FDA on acceptable efficacy
endpoints for the exploratory Phase 2b RESPOND study and future
Phase 3 program, including a number of exploratory endpoints
informed by the findings of the content validity study.
The content validity study included in-depth, qualitative,
semi-structured concept elicitation interviews with premenopausal
(n=23) and postmenopausal (n=13) women who were clinically
diagnosed with FSAD by a trained sexual medicine clinician. The
qualitative data from the interviews revealed a substantial
physical and emotional burden of FSAD. The symptoms and impacts of
this condition underscore the need for FDA-approved treatment
options for pre- and postmenopausal women with FSAD. Results from
this study also suggest that the manifestation and experience of
FSAD are similar in pre- and postmenopausal women and that the
unmet need for an FSAD treatment in the postmenopausal population
is just as great as that of the premenopausal population.
The abstract of the journal article is available online:
https://pubmed.ncbi.nlm.nih.gov/36763961/
“This peer-reviewed article, published in The Journal of Sexual
Medicine, is an important resource for all stakeholders interested
in women’s sexual health and interested in better understanding the
patient experience that informed the exploratory endpoints included
in the Phase 2b RESPOND study in advance of topline data
availability,” said Sabrina Martucci Johnson, President and CEO of
Daré Bioscience. “The findings from this content validity study,
which was completed before commencing the Phase 2b RESPOND study,
furthered our understanding of FSAD, a condition analogous to
erectile dysfunction in men and for which there are currently no
FDA-approved treatment options. Market research suggests that
approximately 10 million women in the United States alone are
distressed from experiencing symptoms associated with FSAD,
including lack of or low sexual arousal, and are actively seeking
solutions to improve their condition. The patient-driven insights
from the content validity study add to our evolving understanding
of her complex journey with FSAD as the findings revealed a
substantial physical and emotional burden associated with FSAD. The
prevalence of FSAD and the symptoms and impacts of the condition
underscore the need for FDA-approved treatment options.”
FSAD is a condition characterized 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. FSAD is distinct from hypoactive sexual desire disorder
(HSDD) in women, which is characterized primarily by a lack of
sexual desire. Of the various types of female sexual dysfunction
disorders, FSAD is most 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 topical
cream formulation of sildenafil specifically designed to increase
blood flow to the genital tissue in women. If development is
successful, Sildenafil Cream has the potential to be the first
FDA-approved treatment for FSAD.
Sildenafil Cream is designed to be applied locally to the
vaginal tissue prior to sexual activity to facilitate vasodilation
and increased blood flow directly to the genital tissue to improve
the physical arousal response symptoms commonly associated with
FSAD while avoiding systemic side effects observed with oral
formulations of PDE-5 inhibitors.
Daré and its collaborator Strategic Science & Technologies,
LLC (SST), a Cambridge, MA based novel topical drug delivery
company, previously announced that topline data for the Phase 2b
RESPOND study is targeted for 2Q-2023. The exploratory Phase 2b
RESPOND study is a multi-center, double-blind, placebo-controlled
study to evaluate the efficacy and safety of Sildenafil Cream, 3.6%
in premenopausal patients with FSAD. The Phase 2b RESPOND study is
a first of its kind Phase 2b clinical study that includes patient
reported outcome (PRO) instruments to screen eligible women with
FSAD and a number of primary, secondary, and exploratory PRO
assessments to measure improvement in localized genital sensations
of arousal and reduction in the distress that women experience with
FSAD. There are no FDA-approved treatments for FSAD and thus there
are no efficacy endpoints that have been previously validated in
Phase 3 pivotal studies for potential treatments for FSAD. The
exploratory Phase 2b RESPOND study is designed to test the
sensitivity of several efficacy endpoints and their ability to
determine a treatment effect of Sildenafil Cream compared to
placebo to inform the ongoing development program.
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.
Daré’s first FDA-approved product, XACIATO™ (clindamycin
phosphate) vaginal gel, 2% is 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. XACIATO is a clear, colorless, viscous gel, to be
administered once intravaginally as a single dose. 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 to treat female sexual arousal disorder
utilizing the active ingredient in Viagra®; 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 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 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 the timing of announcement of topline
data from the Phase 2b RESPOND study of Sildenafil Cream, the
importance of the content validity study, Sildenafil Cream’s
potential as a safe and effective therapy for FSAD, Sildenafil
Cream’s potential to be the first FDA-approved treatment for FSAD,
and the market potential of 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, risk 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; 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 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; the loss of, or
inability to attract, key personnel; the effects of the COVID-19
pandemic, macroeconomic conditions and geopolitical events on
Daré’s operations, financial results and condition, and ability to
achieve current plans and objectives, including the potential
impact of the pandemic on Daré’s ability to timely commence,
enroll, conduct and report results of its clinical trials and on
the ability of third parties on which Daré relies to assist in the
conduct of its business to fulfill their contractual obligations to
Daré; 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; cyber attacks, security
breaches 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:
Investors on behalf of Daré Bioscience, Inc.:
Lee Roth
Burns McClellan
lroth@burnsmc.com
646.930.4406
OR
Media on behalf of Daré Bioscience, Inc.:
Jake Robison
Evoke Canale
jake.robison@evokegroup.com
619.849.5383
Source: Daré Bioscience, Inc.
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