Despite being the most common vaginal
condition,1 BV symptoms are often mistaken for a yeast
infection2
Organon (NYSE: OGN), a global healthcare company with a focus on
women’s health, announced that XACIATO™ (clindamycin phosphate)
vaginal gel 2% is available by prescription to treat bacterial
vaginosis (BV). BV results from an overgrowth of certain bacteria,
which upsets the balance of the natural vaginal microbiome
(environment) and can lead to symptoms of odor and discharge.3 BV
has also been shown to disproportionately affect non-Hispanic Black
and Mexican American women.4,5
In addition to the physical symptoms,3 BV can also impact a
woman’s emotional wellbeing.2 In fact, a 2017 survey among 304
women diagnosed with BV2 found that 79% avoided intimacy with their
partner2 and 68% felt self-conscious because of their condition.2
Most women with symptoms of BV require treatment.6 Women with
recurrent BV have reported frustration with recurrence after
initial treatment,7 with 58% of them experiencing recurrent
infection within 12 months.7
XACIATO, pronounced zah-she-AH-toe, is a colorless single-dose
vaginal gel that can be applied at any time of day and is
formulated with the goal of limiting leakage and increasing vaginal
retention time (time spent in place).4 As demonstrated by an in
vitro study using clindamycin HCl, the gel increases viscosity
(thickness and stickiness) at body temperature and gradually
releases clindamycin, over time.4,8
“As a company focused on women's health, we make it a priority
to listen to women and their providers, so that we understand their
needs and put forward innovative solutions,” said Juan Camilo
Arjona Ferreira, M.D., Head of Research & Development and Chief
Medical Officer at Organon. “What drew us to XACIATO is that it was
formulated with specific needs in mind and studied in a patient
population that was representative of women with BV.”1
XACIATO is contraindicated in individuals with a history of
hypersensitivity to clindamycin or lincomycin. Clostridioides
difficile-associated diarrhea (CDAD) has been reported with use of
nearly all antibacterial agents, including clindamycin, and may
range in severity from mild diarrhea to fatal colitis. Careful
medical history is necessary since CDAD has been reported to occur
over 2 months after the administration of antibacterial agents. If
CDAD is suspected or confirmed, ongoing antibacterial use not
directed against C. difficile may need to be discontinued.
“BV is the most common form of vaginitis,1,9 disrupting the
lives of approximately 21 million women.1,5 For these women, it’s
important to consider her individual treatment needs, such as route
of administration, cost, adverse events, dosing and duration of
treatment,”7,10 said Erica Montes, M.D., Board-Certified
Obstetrician and Gynecologist and a Fellow of the American College
of OB/GYN. “The availability of XACIATO is important as it’s one
dose for women experiencing BV and it can be taken at any time of
day.”
In 2022, Organon and Daré Biosciences completed an agreement
whereby Organon will license global rights to XACIATO.
Information about XACIATO, and the eVoucher instant savings
coupon for eligible patients, can be found at XACIATO.com.
About BV
BV is the most common vaginal condition in women of reproductive
age in the United States, affecting approximately 21 million
women.1,5 The condition results from an overgrowth of certain
bacteria, which upsets the balance of the natural vaginal
microbiome and can lead to symptoms of odor or discharge.3 BV may
self-resolve in up to 30% of women, but most symptomatic women
require treatment.6,11 If left untreated, BV may lead to serious
complications.2,11 BV has also been shown to disproportionately
affect non-Hispanic Black and Mexican American women.4,5
About XACIATO
XACIATO is indicated for the treatment of bacterial vaginosis in
females 12 years and older. A single-dose user-filled disposable
applicator delivers 5g of vaginal gel containing 100mg of
clindamycin.
Selected Safety Information
XACIATO is contraindicated in individuals with a history of
hypersensitivity to clindamycin or lincomycin.
Clostridioides difficile-associated diarrhea (CDAD) has been
reported with use of nearly all antibacterial agents, including
clindamycin, and may range in severity from mild diarrhea to fatal
colitis. Careful medical history is necessary since CDAD has been
reported to occur over 2 months after the administration of
antibacterial agents. If CDAD is suspected or confirmed, ongoing
antibacterial use not directed against C. difficile may need to be
discontinued.
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.
XACIATO may result in the overgrowth of Candida spp. in the
vagina resulting in vulvovaginal candidiasis, which may require
antifungal treatment.
The most common adverse reactions reported in >2% of patients
and at a higher rate in the XACIATO group than in the placebo group
were vulvovaginal candidiasis and vulvovaginal discomfort.
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, maternal
use is not likely to result in significant fetal exposure to the
drug.
There are no data on the effect of clindamycin on milk
production. The developmental and health benefits of breastfeeding
should be considered along with the mother's clinical need for
clindamycin and any potential adverse effects on the breastfed
child from clindamycin or from the underlying maternal
condition.
Please see the Prescribing Information,
Patient Information, and Instructions for
Use.
About Organon
Organon is a global healthcare company formed to focus on
improving the health of women throughout their lives. Organon
offers more than 60 medicines and products in women’s health in
addition to a growing biosimilars business and a large franchise of
established medicines across a range of therapeutic areas.
Organon’s existing products produce strong cash flows that support
investments in innovation and future growth opportunities in
women’s health and biosimilars. In addition, Organon is pursuing
opportunities to collaborate with biopharmaceutical innovators
looking to commercialize their products by leveraging its scale and
presence in fast growing international markets.
Organon has a global footprint with significant scale and
geographic reach, world-class commercial capabilities, and
approximately 10,000 employees with headquarters located in Jersey
City, New Jersey.
For more information, visit http://www.organon.com and connect
with us on LinkedIn, Instagram, X (formerly known as Twitter) and
Facebook.
Forward-Looking Statements
Some statements and disclosures in this press release are
“forward-looking statements” within the meaning of the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of
1995, including, but not limited to, statements regarding product
development and commercialization plans for XACIATO.
Forward-looking statements include all statements that do not
relate solely to historical or current facts and can be identified
by the use of words such as "may," “expects,” “intends,”
“anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will,”
or words of similar meaning. These forward-looking statements are
based on our current plans and expectations and are subject to a
number of significant risks and uncertainties. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from the forward-looking
statements.
Risks and uncertainties that may affect our future results
include, but are not limited to, an inability to fully execute on
the nationwide commercialization plans for XACIATO; our product
development and commercialization plans within the United States or
internationally; an inability to adapt to the industry-wide trend
toward highly discounted channels; changes in tax laws or other tax
guidance which could adversely affect our cash tax liability,
effective tax rates, and results of operations and lead to greater
audit scrutiny; an inability to execute on our business development
strategy or realize the benefits of our planned acquisitions;
efficacy, safety, or other quality concerns with respect to
marketed products, including market actions such as recalls,
withdrawals, or declining sales; political and social pressures, or
regulatory developments, that adversely impact demand for,
availability of, or patient access to contraception and fertility
products; general economic factors, including recessionary
pressures, interest rate and currency exchange rate fluctuations;
general industry conditions and competition; the impact of the
ongoing COVID-19 pandemic and emergence of variant strains; the
impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances; new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict its future
financial results and performance; manufacturing difficulties or
delays; financial instability of international economies and
sovereign risk; difficulties developing and sustaining
relationships with commercial counterparties; dependence on the
effectiveness of the company’s patents and other protections for
innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s filings
with the Securities and Exchange Commission ("SEC"), including the
company’s Annual Report on Form 10-K for the year ended December
31, 2022 and subsequent SEC filings, available at the SEC’s
Internet site (www.sec.gov).
1 Bacterial vaginosis statistics. Centers for Disease Control
and Prevention. Last reviewed February 10, 2020. Accessed October
19, 2023. https://www.cdc.gov/std/bv/stats.htm
2 Understanding women’s experiences with bacterial vaginosis.
American Sexual Health Association. Accessed October 19, 2023.
https://www.ashasexualhealth.org/understanding-womens-experiences-with-bacterial-vaginosis/
3 Bacterial vaginosis - CDC basic fact sheet. Centers for
Disease Control and Prevention. January 5, 2022. Accessed October
19, 2023.
https://www.cdc.gov/std/bv/stdfact-bacterial-vaginosis.htm
4 Mauck C, Hillier SL, Gendreau J, et al. Single-dose
bioadhesive clindamycin 2% gel for bacterial vaginosis. Obstet
Gynecol. 2022;00:1–11. DOI: 10.1097/AOG.0000000000004805.
5 Koumans EH, Sternberg M, Bruce C, et al. The prevalence of
bacterial vaginosis in the United States, 2001-2004; associations
with symptoms, sexual behaviors, and reproductive health. Sex
Transm Dis. 2007;34(11):864-9.
6 Bacterial vaginosis. Centers for Disease Control and
Prevention. July 19, 2021. Accessed October 19, 2023.
https://www.cdc.gov/std/treatment-guidelines/bv.htm
7 Muzny CA, Kardas P. A Narrative Review of Current Challenges
in the Diagnosis and Management of Bacterial Vaginosis. Sex Transm
Dis. 2020 Jul;47(7):441-446. doi: 10.1097/OLQ.0000000000001178.
PMID: 32235174; PMCID: PMC7294746.
8 Mondal P, Hemant AH, Johnston TP. Evaluation of TRI-726 as a
drug delivery matrix. Drug Dev Ind Pharm. 2011;37(8):995-1001.
doi:10.3109/03639045.2011.555913
9 Paladine HL, Desai UA. Vaginitis: diagnosis and treatment. Am
Fam Physician. 2018;97(5):321-329.
10 Chavoustie SE, Eder SE, Koltun WD, et al. Experts explore the
state of bacterial vaginosis and the unmet needs facing women and
providers. Int J Gynaecol Obstet. 2017;137(2):107-109.doi:
10.1002/ijgo.12114.
11 Kairys N, Garg M. Bacterial vaginosis. NCBI Bookshelf.
Updated July 4, 2023. Accessed October 5, 2023.
https://www.ncbi.nlm.nih.gov/books/NBK459216/
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