Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s
health innovation, today announced that the U.S. Food and Drug
Administration (FDA) approved XACIATO [zah-she-AH-toe] (clindamycin
phosphate vaginal gel, 2%) (formerly known as DARE-BV1) for the
treatment of bacterial vaginosis in females 12 years of age and
older.
“The FDA approval of XACIATO marks a major milestone not only
for Daré as a company but, importantly, for the 21 million women
impacted by bacterial vaginosis,” said Sabrina Martucci Johnson,
President and CEO of Daré Bioscience. “It is our goal as a company
to accelerate the development of differentiated products that can
improve outcomes and convenience for women. In the case of XACIATO,
this FDA approval comes just three years after we licensed this
technology. We are grateful to the FDA for their thoughtful review
and the alignment on labeling that gives healthcare providers clear
insights into how to use XACIATO in those patient populations in
greatest need of a therapeutic option, such as pregnant women and
women with recurrent episodes of bacterial vaginosis. We hope that
this is the first of many FDA approvals in our efforts to improve
the lives of women with treatment options that address some of the
most persistent unmet needs.”
“Bacterial vaginosis is not a sexually transmitted infection,
but rather an overgrowth of bacteria naturally found in the vagina,
which upsets the balance of the natural vaginal microbiome and
leads to not only distressing symptoms of odor and discharge, but
also increases a woman's risk of preterm birth, infertility, and
infections. Today, approximately half of the women treated
for bacterial vaginosis experience a recurrence within 12 months of
treatment. There is a need for more efficacious and
convenient treatment options, particularly products with improved
clinical outcomes for not only the newly diagnosed women, but,
importantly, also for the women who experience multiple episodes of
bacterial vaginosis each year,” said David Friend, Ph.D., Daré’s
Chief Scientific Officer. “Now that we have achieved this important
demonstration of this drug delivery hydrogel platform technology,
we are actively exploring the opportunity to leverage it across
other unmet needs in women's health.”
About Bacterial Vaginosis
Bacterial vaginosis is the most common cause of vaginitis
worldwide and is estimated to affect approximately 21 million women
in the United States.1,2 Prevalence of bacterial vaginosis among
non-white women in the U.S. is higher than among white women
(African American 51%, Mexican American 32%, white 23%).2 Bacterial
vaginosis can cause serious health risks and very disruptive
symptoms. While there are several therapeutic options for women in
the U.S. diagnosed with bacterial vaginosis, currently approved
options have relatively insufficient clinical cure rates, require
sequential daily administrations or can be otherwise inconvenient
for women to use. It is estimated that as many as 50% of women
treated for bacterial vaginosis will experience a recurrence within
12 months of their treatment.3
- Clinical Infectious Diseases 2007;
44:213–9; https://doi.org/10.1086/509577
- Centers for Disease Control and
Prevention Bacterial Vaginosis (BV) Statistics;
https://www.cdc.gov/std/bv/stats.htm. Accessed December 7,
2021.
- The Journal of Infectious Diseases 2006; 193:1478–86;
https://www.ncbi.nlm.nih.gov/pubmed/16652274
About
XACIATOTM (clindamycin phosphate)
Vaginal Gel
XACIATO is the trade name for clindamycin phosphate vaginal gel,
2%. XACIATO is a lincosamide antibacterial indicated for the
treatment of bacterial vaginosis in female patients 12 years of age
and older. XACIATO is a clear, colorless, viscous gel, which
contains clindamycin at a concentration of 2% (present as
clindamycin phosphate). A single-dose user-filled disposable
applicator delivers 5 g of vaginal gel containing 100 mg of
clindamycin. The New Drug Application (NDA) for XACIATO was
approved by the FDA on December 7, 2021.
The NDA was supported by positive results from the DARE-BVFREE
Phase 3 randomized, multi-center, double-blinded,
placebo-controlled clinical trial evaluating XACIATO in women
diagnosed with bacterial vaginosis (NCT04370548).
XACIATO received both Qualified Infectious Disease Product
(QIDP) and Fast Track designations from the FDA for the treatment
of bacterial vaginosis. As a result of the QIDP designation,
XACIATO is expected to receive a five-year extension of the three
years of market exclusivity available to the product based on the
submission of new clinical data that were essential to its
approval. Strategic partnering discussions and other activities
intended to support a robust market introduction of XACIATO in 2022
in the United States are ongoing and a conference call to discuss
the partnership and market introduction strategy will be scheduled
once a definitive partnership agreement is finalized and
executed.
Please click here for full Prescribing Information.
Important Safety Information
Indication: XACIATO (clindamycin phosphate)
vaginal gel is a lincosamide antibacterial indicated for the
treatment of bacterial vaginosis in female patients 12 years of age
and older.
Dosage and Administration: Administer one
applicatorful (5 g of gel containing 100 mg of clindamycin) once
intravaginally as a single dose at any time of the day. Not for
ophthalmic, dermal, or oral use.
Contraindications: XACIATO is contraindicated
in patients with a history of hypersensitivity to clindamycin or
lincomycin.
Warnings and Precautions:
- Clostridioides difficile-Associated Diarrhea (CDAD):
Discontinue and evaluate if diarrhea occurs
- Use with Polyurethane Condoms: Polyurethane condoms are not
recommended during treatment with XACIATO or for 7 days following
treatment. During this time period, polyurethane condoms may not be
reliable for preventing pregnancy or for protecting against
transmission of HIV and other sexually transmitted diseases. Latex
or polyisoprene condoms should be used.
Adverse Reactions: The most common adverse
reactions reported in >2% of patients in the Phase 3
placebo-controlled trial and at a higher rate in the XACIATO group
than in the placebo group were vulvovaginal candidiasis and
vulvovaginal discomfort.
Drug Interactions: Systemic clindamycin has
neuromuscular blocking properties that may enhance the action of
other neuromuscular blocking agents. It should be used with caution
in patients receiving such agents.
Use in Specific Populations:
- Other clindamycin vaginal products have been used to treat
pregnant women during the second and third trimester. XACIATO has
not been studied in pregnant women. However, based on the low
systemic absorption of XACIATO following the intravaginal route of
administration in nonpregnant women, material use is not likely to
result in significant fetal exposure to the drug.
- Similarly, because systemic absorption following intravaginal
administration of clindamycin is low, transfer of the drug into
breastmilk is likely to be low and adverse effects on the breastfed
infant are not expected.
- The safety and effectiveness of XACIATO have not been
established in pediatric patients younger than 12 years of
age.
To report SUSPECTED ADVERSE REACTIONS, contact Daré
Bioscience at 866-XACIATO (866-922-4286) or FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
About Daré Bioscience
Daré Bioscience is a clinical-stage 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 product portfolio includes potential first-in-category
candidates in clinical development: Ovaprene®, a novel,
hormone-free monthly 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. Daré’s New Drug Application (NDA) for XACIATO
(clindamycin phosphate) vaginal gel (formerly known as DARE-BV1)
was approved by the FDA on December 7, 2021. To learn more about
Daré’s full portfolio of women’s health product candidates, and
mission to deliver differentiated therapies for women, please
visit www.darebioscience.com.
Daré may announce material information about its finances,
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 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 on
the investor relations page of Daré’s website mentioned above.
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,” 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 a commercial partnership for XACIATO, the
timing of commercial launch of XACIATO in the U.S., XACIATO’s
potential to be prescribed as a first line option for the treatment
of bacterial vaginosis, and the potential for Daré’s development of
other women’s health products utilizing the drug delivery hydrogel
technology in XACIATO. 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 establish
commercialization arrangements or capabilities for XACIATO on a
timely basis or on acceptable terms, or at all; Daré’s reliance on
third parties for the commercialization of XACIATO, including
manufacturing, distribution, marketing, sales and compliance
capabilities; the risk that XACIATO may not be accepted by
healthcare providers and patients; the risk that XACIATO will not
obtain adequate coverage, pricing or reimbursement from third-party
payors; 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 to timely establish or leverage
third-party partnerships or collaborations to commercialize Daré’s
product candidates, if approved; 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 clinical trial material,
and if any of its product candidates are approved, to manufacture
commercial product; 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 effects of
the COVID-19 pandemic 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 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, including its clinical trials, to
fulfill their contractual obligations to Daré; 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 developments by competitors make Daré’s product candidates
less competitive or obsolete; failure of Daré’s product candidates,
if approved, to gain market acceptance or obtain adequate coverage
from third-party payers; Daré’s ability to retain its licensed
rights to develop and commercialize a 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 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; 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
McClellanlroth@burnsmc.com212.213.0006
OR
Media on behalf of Daré Bioscience, Inc.:Jake RobisonCanale
Communicationsjake.robison@canalecomm.com 619.849.5383
Source: Daré Bioscience, Inc.
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