Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health
innovation, today announced the start of a Phase 1 study evaluating
its development program targeted at treating primary dysmenorrhea
by delivering the active pharmaceutical ingredient diclofenac, a
nonsteroidal anti-inflammatory drug (NSAID), in a novel way. Daré’s
investigational product, DARE-PDM1, will deliver diclofenac
vaginally via the Company’s proprietary hydrogel.
Primary dysmenorrhea is defined as painful
menstruation in women with normal pelvic anatomy, typically
described as cramping pain in the lower abdomen before or during
the menstrual period. Recent market research suggests that the
global market for dysmenorrhea treatment was estimated to be valued
at USD $13 billion in 2022 and that the size of this market is
expected to increase to USD $28.5 billion by 2029¹.
Oral NSAIDs, such as diclofenac, are often
recommended for temporary relief from the painful symptoms of
primary dysmenorrhea². Because there are currently no FDA-approved
vaginal diclofenac treatment options for primary dysmenorrhea,
DARE-PDM1 has the potential to be a first-in-category product,
delivering diclofenac in a convenient vaginal format that may
extend the duration of pain relief and reduce the risks associated
with the oral delivery of NSAIDs.
“The potential benefits of DARE-PDM1 as a
potential treatment for the millions of women suffering from
primary dysmenorrhea are driven by its unique target product
profile,” said Sabrina Martucci Johnson, President and CEO of Daré
Bioscience. “Its key attributes include the utilization of a
well-known and well-characterized active pharmaceutical ingredient
for the condition, delivery of the active utilizing our novel
hydrogel delivery technology which is designed to keep the product
from leaking out of the vagina and may increase the vaginal
residence time and, most importantly, the opportunity for local
vaginal administration to reduce the frequency and severity of
systemic side effects associated with commonly recommended and
prescribed oral medications, such as oral NSAIDs and oral hormone
contraceptive products.”
Primary dysmenorrhea usually begins during
adolescence and is a leading cause of recurrent short-term school
absence in adolescent girls and a common problem in women of
reproductive age. According to the American College of
Obstetricians and Gynecologists’ Committee on Adolescent
Health Care, dysmenorrhea is the most common menstrual symptom
among adolescent girls and young women, and most adolescents
experiencing dysmenorrhea have primary dysmenorrhea. Prevalence
rates of dysmenorrhea vary but range from 50% to 90%. A prospective
study of college students found that 72% of monitored periods were
painful, most commonly during the first day of menses, and 60% of
the women studied reported at least one episode of severe pain.
“The most common interventions for primary
dysmenorrhea include oral NSAIDs and hormonal contraceptives which
often can produce undesirable side effects. Oral NSAIDs, which are
available over the counter, may cause an increased risk of
gastrointestinal adverse events, including nausea, vomiting,
bloating or ulcerations, and hormonal contraceptives can often
produce a number of undesirable side effects,” said Dr. Annie
Thurman, Medical Director of Daré Bioscience. “Local drug delivery
through the vaginal mucosa allows lower doses that specifically
target local genital tissues and the myometrium. By leveraging a
vaginal route of administration, we believe we can provide a
treatment option that addresses the pain-related symptoms of the
condition while minimizing side effects commonly seen with use of
oral medications.”
The DARE-PDM1 Phase 1 study, DARE-PDM1-001, is a
multi-center, randomized, placebo-controlled, double-blind, 3 arm
parallel group study of approximately 36 healthy, premenopausal
women with primary dysmenorrhea. This study is designed to assess
the systemic (plasma) and local mucosal (vaginal fluid) diclofenac
pharmacokinetics (PK) and safety after a single dose and during
three daily doses of vaginally administered DARE-PDM1, given in two
different strengths (1% or 3% diclofenac in 2.5 mL of hydrogel)
versus placebo. The study will also assess, as an exploratory
endpoint, the preliminary dysmenorrhea treatment efficacy of
DARE-PDM1, when dosed in three daily doses at the onset of
dysmenorrhea symptoms, compared to a no-treatment, baseline,
control cycle. The study observation period will encompass
approximately three menstrual cycles.
The DARE-PDM1-001 study will be conducted in
Australia by the company’s subsidiary, DARE Bioscience Australia
Pty Ltd.
At the conclusion of the development program, if
successful, Daré intends to leverage the existing safety and
efficacy data for diclofenac to utilize the U.S. Food and Drug
Administration’s (FDA) 505(b)(2) pathway to obtain marketing
approval of DARE-PDM1 in the U.S.
-
https://www.reanin.com/report-store/healthcare/pharmaceuticals-and-therapeutics/dysmenorrhea-treatment/global-dysmenorrhea-treatment-market
-
https://my.clevelandclinic.org/health/drugs/11086-non-steroidal-anti-inflammatory-medicines-nsaids
About Daré BioscienceDaré
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, fertility, and vaginal and
sexual health.
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 hormone therapy following menopause. 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 StatementsDaré
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 plans and expectations with respect to
DARE-PDM1 and its potential benefits, the anticipated conduct of
the Phase 1 study for DARE-PDM1, the potential for DARE-PDM1 to be
a first-in-category product, expectations regarding the future
market size for dysmenorrhea treatment, and the potential
regulatory approval pathway for DARE-PDM1. 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 those expressed or
implied by the forward-looking statements in this press release,
including, without limitation: 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; 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; Daré’s ability to develop, obtain FDA or
foreign regulatory approval for, and commercialize its product
candidates and to do so on communicated timelines; Daré’s
dependence on third parties to conduct clinical trials and
manufacture and supply clinical trial material and commercial
product; the risk that development of a product candidate requires
more clinical or nonclinical studies than Daré anticipates, or that
the duration of a study or number of study subjects is
significantly greater than anticipated; 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 loss of, or inability to attract, key personnel; the
effects of the COVID-19 pandemic, macroeconomic conditions such as
inflation, rising interest rates 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 RothBurns
McClellanlroth@burnsmc.com646.930.4406
OR
Media on behalf of Daré Bioscience, Inc.:Jake
RobisonEvoke Canalejake.robison@evokegroup.com619.849.5383
Source: Daré Bioscience, Inc.
Dare Bioscience (NASDAQ:DARE)
Historical Stock Chart
From Jun 2024 to Jul 2024
Dare Bioscience (NASDAQ:DARE)
Historical Stock Chart
From Jul 2023 to Jul 2024