Builds on Current Momentum Towards Broadening Access to This
Contraceptive Option for Women Across the Globe
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. announced today that the company’s injectable contraceptive,
Sayana® Press (medroxyprogesterone acetate), is now available
to women in the United Kingdom (UK) for administration by
self-injection. This follows the recent approval from the UK Medicines
and Healthcare Products Regulatory Agency (MHRA) of an update to the
Sayana® Press label, adding the option for self-injection by
women when considered appropriate by a healthcare professional (HCP).
Sayana® Press is the first injectable contraceptive in the UK
available for administration via self-injectioni,ii. This new
method of administration is also approved or pending local approval in
additional European Union (EU) markets (Austria, Belgium, Hungary,
Ireland, Netherlands). Pfizer will continue its efforts to help bring
this updated label to more countries across the globe, with an initial
focus on those in the developing world – such as in Burkina Faso,
Senegal and Uganda – where data show unmet neediii and demand
for injectable contraceptivesiv. Sayana® Press is not yet
approved for self- injection outside of the EU.
“With this revised label, following consent from a healthcare
professional and with proper training, UK women will now have the
opportunity to administer Sayana® Press outside of a clinical setting,”
said Dr. Salomon Azoulay, senior vice president and chief medical
officer, Pfizer Global Established Pharma Business. “This is an exciting
milestone for women in the United Kingdom, and, potentially, in
countries around the world, who might prefer this method of
contraception and mode of administration.”
Sayana® Press combines a long-acting, reversible,
contraceptive with an all-in-one prefilled, single-use, non-reusable
Uniject™ injection system, eliminating the need to prepare a needle and
syringe. Approved for use by the MHRA in 2011, the contraceptive is
indicated for the prevention of pregnancy. Each subcutaneous injection
prevents ovulation and provides contraception for at least 13 weeks (+/-
one week). Sayana® Press professional and patient
information, including the risk of bone mineral density loss and other
warnings and precautions for use, can be found here.
Injectable contraceptives are a widely-used family planning method,
particularly among women in developing countriesv. They are
discreetvi, eliminate the need for a daily pill regimenvii
and, for some women living in remote areas, they can alleviate the
deterrent of having to frequently travel long distances to get to a
clinicviii. Accordingly, experts have identified the need for
a contraceptive method that can be administered in low-resource,
In November 2014, Pfizer Inc., the Bill & Melinda Gates Foundation and
the Children’s Investment Fund Foundation (CIFF) entered into a
partnership to help broaden access to Sayana® Press for women
most in need in 69 of the world’s poorest countriesx. Through
this collaboration, Sayana® Press is being sold for US $1 per
dose to qualified purchasers, who help enable the poorest women in these
countries to have access to the contraceptive at reduced or no cost. The
agreement is supported by a consortium of private sector donors and aid
organizations, which include PATH, United Kingdom’s Department for
International Development (DFID), the United Nations Population Fund
(UNFPA) and the United States Agency for International Development
“Helping to broaden access to Sayana® Press is a key priority for
Pfizer,” said John Young, president, Pfizer Global Established Pharma
Business. “Through the tremendous efforts and ongoing collaboration with
our Partners, we have already made great progress in bringing Sayana®
Press to thousands of women living in sub-Saharan Africa. We hope to
continue the great momentum achieved, enabling us to further help
address the specific family planning needs of women in the developing
In July 2014, this same consortium of public and private organizations
piloted efforts to help make Sayana® Press available for the
first time in four countries in sub-Saharan Africa. Through June 2015,
more than 170,600 Sayana® Press units have been distributed to health
facilities across Burkina Faso, Niger, Senegal and Uganda. In addition,
over 6,000 health care providers were trained on Sayana® Press
Sayana® Press is approved by regulatory authorities in the
European Union and in a number of countries across the globe, including
Bangladesh, Burkina Faso, Kenya, Niger, Nigeria, Senegal and Uganda.
Additional regulatory submissions are being pursued.
Important Safety Information
SAYANA® PRESS should not be used in women with known or
suspected malignancy of the breast or genital organs, metabolic bone
disease, active thromboembolic disease and in women with current or past
history of cerebrovascular disease.
Use of SAYANA® PRESS is associated with significant loss of
bone mineral density (BMD). This loss of BMD is of particular concern
during adolescence and early adulthood, a critical period of bone
accretion. Decrease in BMD during treatment appears to be substantially
reversible after depot medroxyprogesterone acetate (DMPA) injection is
Re-evaluation of the risks and benefits of treatment should be carried
out in all women who wish to continue use for more than 2 years.
Most women using DMPA SC experience a change in menstrual bleeding
patterns. Bleeding may be heavy.
No information is available that would support the safety of DMPA SC use
in women with a history of thromboembolic disease.
Women may gain weight on DMPA. MPA may cause some degree of fluid
There is a potential for delay in return to ovulation following use of
DMPA SC, regardless of the duration of use.
Monitor patients with a history of clinical depression or diabetes
DMPA SC does not protect against HIV infection (AIDS) or other sexually
Injection site reactions such as injection site pain, injection site
tenderness, injection site nodules, injection site atrophy (persistent)
and lipoatrophy of the injection site have been reported with DMPA SC
104 mg/0.65 mL suspension for injection (pre-filled syringe).
The most common adverse events in phase 3 clinical trials of DMPA-SC
included amenorrhea, heavy intermenstrual bleeding, weight gain and
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies
to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
development and manufacture of health care products. Our global
portfolio includes medicines and vaccines as well as many of the world’s
best-known consumer health care products. Every day, Pfizer colleagues
work across developed and emerging markets to advance wellness,
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more than 150 years, Pfizer has worked to make a difference for all who
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DISCLOSURE NOTICE: The information contained in this release is as of
September 24, 2015. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result of
new information or future events or developments.
This release contains forward-looking information related to the
roll-out of Sayana Press and the potential benefits of Sayana Press that
involves substantial risks and uncertainties that could cause actual
results to differ materially from those expressed or implied by such
statements. Risks and uncertainties include, among other things, the
uncertainties inherent in research and development; whether and when any
applications for Sayana Press or label updates for Sayana Press may be
filed with regulatory authorities in any other jurisdictions; whether
and when regulatory authorities may approve such applications and any
other applications that are pending for Sayana Press, which will depend
on the assessment by such regulatory authorities of the benefit-risk
profile suggested by the totality of the efficacy and safety information
submitted; decisions by regulatory authorities regarding labeling and
other matters that could affect the availability or commercial potential
of Sayana Press; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended December
31, 2014, including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 10-Q and Form
8-K, all of which are filed with the SEC and available at www.sec.gov
i National Health Service. The
Contraceptive Injection. Available at: http://www.nhs.uk/conditions/contraception-guide/pages/contraceptive-injection.aspx.
Accessed: September 8, 2015.
ii Electronic Medicines
Compendium. Noristerat SPC. Available at: http://www.medicines.org.uk/emc/medicine/1835.
Accessed: September 8, 2015.
iii FP 2020 Progress
Report: 2013-2014. Figures 4.14, AX. 12 and AX. 12. Available at: http://progress.familyplanning2020.org/downloads.
Accessed: July 27, 2015.
iv FP 2020 Progress Report:
2013-2014. Figures 4.12, AX. 4 and AX. 18. Available at: http://progress.familyplanning2020.org/downloads.
Accessed: July 27, 2015.
v United Nations. World
Contraceptive Patterns 2013. Available at: www.un.org/en/development/desa/population/publications/pdf/family/worldContraceptivePatternsWallChart2013.pdf.
Accessed: November 4, 2014.
vi Family Planning 2020. FP2020:
Partnership in Progress 2013-2014. Available at: progress.familyplanning2020.org/uploads/ckfinder/files/FP2020_Progress_Report_2013-2014_Digital_View_lores.pdf.
Family Planning 2020. FP2020: Partnership in Progress 2013-2014.
Available at: progress.familyplanning2020.org/uploads/ckfinder/files/FP2020_Progress_Report_2013-2014_Digital_View_lores.pdf.
World Health Organization. Family Planning Fact Sheet. Available
UNFPA. Adding it Up: Costs and Benefits of Contraceptive Services.
Estimates for 2012. Available at: https://www.unfpa.org/webdav/site/global/shared/documents/publications/2012/AIU%20Paper%20-%20Estimates%20for%202012%20final.pdf.
Accessed: November 7, 2014.
x Family Planning 2020.
Available at: http://www.familyplanning2020.org/countries/all-countries.
Accessed: November 5, 2014.
xi PATH data on file.