Opella reaches study milestone for Cialis
Paris, January 21, 2025.
Opella, Sanofi’s Consumer Healthcare business, announced that the
US Food and Drug Administration (FDA) has lifted a clinical hold on
its planned actual use trial (AUT) to support the switch of Cialis
(tadalafil) from a prescription to an over-the-counter medicine.
This decision allows for the initiation of the AUT and makes Cialis
the first PDE-5 inhibitor to achieve this milestone.
AUTs evaluate the use of the medicine under
real-world conditions to identify any issues that have not
previously been identified and to confirm that consumers can
self-diagnose and treat themselves appropriately without the help
of a healthcare provider.
Julie Van OngevallePresident
and CEO, Opella“We are pleased that the FDA has completed their
review and is allowing us to initiate this important study. The
actual use trial is not only a significant opportunity to gain
insights into how Cialis is used by consumers without a
prescription, but it also underscores our commitment to advancing
self-care solutions. It represents a crucial step towards our
commitment to make self-care as simple as it should be.”
Dr. Josephine FubaraChief
Science Officer, Opella“FDA’s decision marks a significant step
forward in Opella’s data-driven efforts to switch a PDE-5 inhibitor
like Cialis. Now that the FDA has completed their thorough review
of our data, we can move into the next phase of this program; the
actual use trial, which is pivotal in ensuring the safety and
proper self-selection of Cialis for over-the-counter use. We look
forward to continuing our work to bring safe and expanded access to
the many consumers who will benefit from nonprescription
Cialis.”
Opella remains committed to advancing its
development program and bringing a new self-care solution with
proven effectiveness for people living with erectile dysfunction.
The company is completing the clinical and regulatory activities
necessary to initiate the pivotal AUT. Information about the study
will become available on clinicaltrials.gov.
On October 21, 2024 Sanofi and CD&R
announced the intention to transfer a 50% controlling stake in
Opella to CD&R with Sanofi to remain a significant
shareholder.
About CialisCialis (tadalafil)
in the US is currently only available with a prescription. Cialis
is a tablet taken to treat erectile dysfunction (ED), the signs and
symptoms of benign prostatic hyperplasia (BPH), and both ED and the
signs and symptoms of BPH. Cialis is the only PDE-5 inhibitor
treatment that offers men a choice when it comes to treatment for
ED - Cialis for use as needed and Cialis for once daily use. To
learn more about Cialis, visit www.cialis.com.
Cialis is not for women or children. It is
important to note that Cialis is not to be taken with medicines
called nitrates such as isosorbide dinitrate or isosorbide
mononitrate which are often prescribed for chest pain; or with
recreational drugs called poppers like amyl or butyl nitrite, as
the combination may cause an unsafe drop in blood pressure; or if
allergic to Cialis or Adcirca (tadalafil), or any of its
ingredients. Anyone who experiences any symptoms of an allergic
reaction, such as rash, hives, swelling of the lips, tongue or
throat, or difficulty breathing or swallowing, should call a
healthcare provider or get help right away.
About Sanofi We are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across the world, is
dedicated to transforming the practice of medicine by working to
turn the impossible into the possible. We provide potentially
life-changing treatment options and life-saving vaccine protection
to millions of people globally, while putting sustainability and
social responsibility at the center of our ambitions.Sanofi is
listed on EURONEXT: SAN and NASDAQ: SNY
Sanofi Media RelationsSandrine
Guendoul | +33 6 25 09 14 25 |
sandrine.guendoul@sanofi.com Evan Berland | +1 215
432 0234 | evan.berland@sanofi.comNicolas Obrist |
+33 6 77 21 27 55 | nicolas.obrist@sanofi.com Léo Le
Bourhis | +33 6 75 06 43 81 |
leo.lebourhis@sanofi.comVictor Rouault | +33 6 70
93 71 40 | victor.rouault@sanofi.com Timothy
Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com
Opella Media RelationsJustine
Rohée | +33 6 86 47 85 60 | justine.rohee@sanofi.com
Sanofi Investor RelationsThomas Kudsk
Larsen |+44 7545 513 693 |
thomas.larsen@sanofi.comAlizé Kaisserian | +33 6
47 04 12 11 | alize.kaisserian@sanofi.com Felix
Lauscher | +1 908 612 7239 |
felix.lauscher@sanofi.comKeita Browne | +1 781 249
1766 | keita.browne@sanofi.com Nathalie Pham | +33
7 85 93 30 17 | nathalie.pham@sanofi.com Tarik
Elgoutni | +1 617 710 3587 |
tarik.elgoutni@sanofi.comThibaud Châtelet | +33 6
80 80 89 90 | thibaud.chatelet@sanofi.com
Sanofi forward-looking
statementsThis press release contains forward-looking
statements as defined in the Private Securities Litigation Reform
Act of 1995, as amended. Forward-looking statements are statements
that are not historical facts. These statements include projections
and estimates and their underlying assumptions, statements
regarding plans, objectives, intentions, and expectations with
respect to future financial results, events, operations, services,
product development and potential, and statements regarding future
performance. Forward-looking statements are generally identified by
the words “expects”, “anticipates”, “believes”, “intends”,
“estimates”, “plans” and similar expressions. Although Sanofi’s
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned
that forward-looking information and statements are subject to
various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of Sanofi, that could
cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking
information and statements. These risks and uncertainties include
among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post
marketing, decisions by regulatory authorities, such as the FDA or
the EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the fact that product candidates if
approved may not be commercially successful, the future approval
and commercial success of therapeutic alternatives, Sanofi’s
ability to benefit from external growth opportunities, to complete
related transactions and/or obtain regulatory clearances, risks
associated with intellectual property and any related pending or
future litigation and the ultimate outcome of such litigation,
trends in exchange rates and prevailing interest rates, volatile
economic and market conditions, cost containment initiatives and
subsequent changes thereto, and the impact that pandemics or other
global crises may have on us, our customers, suppliers, vendors,
and other business partners, and the financial condition of any one
of them, as well as on our employees and on the global economy as a
whole. The risks and uncertainties also include the uncertainties
discussed or identified in the public filings with the SEC and the
AMF made by Sanofi, including those listed under “Risk Factors” and
“Cautionary Statement Regarding Forward-Looking Statements” in
Sanofi’s annual report on Form 20-F for the year ended December 31,
2023. Other than as required by applicable law, Sanofi does not
undertake any obligation to update or revise any forward-looking
information or statements.All trademarks mentioned in this press
release are the property of the Sanofi group.
Sanofi (EU:SAN)
Historical Stock Chart
From Dec 2024 to Jan 2025
Sanofi (EU:SAN)
Historical Stock Chart
From Jan 2024 to Jan 2025
