Press Release: Update on Cialis® Rx-to-OTC Switch Actual Use Trial
Update on Cialis® Rx-to-OTC Switch Actual Use Trial
Paris. May 30, 2022. The U.S. Food and Drug Administration has officially communicated to Sanofi that the company’s proposed Actual Use Trial (AUT), which is intended to substantiate the switch of Cialis® (tadalafil) from a prescription medication to an over-the-counter option, has been placed on clinical hold. This hold stems from concerns surrounding specific aspects of the protocol design that the FDA has raised. It is essential to note that, as of this date, Sanofi has not yet commenced the recruitment of participants for the trial. Nevertheless, the company remains actively engaged in discussions with the FDA, seeking to address the agency's concerns and advance the Cialis® program. Sanofi is committed to holding a series of productive meetings with FDA representatives in order to outline and determine the appropriate next steps in the trial process.
About Cialis
Presently, Cialis is available exclusively via prescription and is prescribed in tablet form to effectively treat erectile dysfunction (ED) as well as the signs and symptoms associated with benign prostatic hyperplasia (BPH). Cialis represents a unique treatment option as it is the only PDE-5 inhibitor available that provides men with flexible dosing options—either as a medication for use on an as-needed basis or for daily use. If you would like further information regarding Cialis, you can visit the official website at www.cialis.com.
It is crucial to emphasize that Cialis is not intended for use by women or children. Additionally, it should not be ingested concurrently with medications known as "nitrates," such as isosorbide dinitrate or isosorbide mononitrate, which are commonly prescribed to treat chest pain. The combination of Cialis with recreational substances known as "poppers," including amyl or butyl nitrite, poses risks, as these combinations may lead to dangerously low blood pressure. Patients should also avoid Cialis if they have a known allergy to its active ingredient, tadalafil, or to other formulations, such as Adcirca®. In the event of experiencing any signs of an allergic reaction, including but not limited to rash, hives, or swelling of the lips, tongue, or throat, or difficulties in breathing or swallowing, immediate consultation with a healthcare provider is advised.
About Sanofi
As a pioneering global healthcare entity, Sanofi is driven by a singular mission: to pursue the marvels of science to enhance and transform the lives of patients globally. Our dedicated teams, spanning approximately 100 countries, are relentlessly working to revolutionize the field of medicine, striving to convert the seemingly impossible into feasible solutions. We offer potentially life-saving treatment options and groundbreaking vaccine protections to millions worldwide, while weaving sustainability and social responsibility into the very fabric of our corporate objectives.
Sanofi is proudly listed on EURONEXT under the symbol SAN and on NASDAQ as SNY.
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Sanofi Forward-Looking Statements
This press release includes forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are those that extend beyond historical facts. Such statements encompass projections, estimates, and the underlying assumptions, as well as declarations regarding strategic plans, objectives, intentions, and expectations associated with future financial performance, operational events, services, product development, and potential. These forward-looking assertions are typically identified by terms such as “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” and similar phrases. While Sanofi's management holds a belief that the expectations communicated through forward-looking statements are sound and reasonable, investors should be aware that forward-looking information is fraught with risks and uncertainties, many of which are challenging to forecast and generally exist beyond Sanofi's control, potentially leading to significant variances from actual outcomes and developments. These risks encompass a wide array of factors, including inherent uncertainties related to research and development initiatives, the interpretation of future clinical data, regulatory authority decisions—including those from the FDA or EMA—regarding the timeliness of approvals for any filed drug, device, or biological applications, as well as determinations relating to labeling and other aspects that might impact availability or commercial potential. Product candidates, even if approved, may face lackluster commercial success, and there remains uncertainty surrounding the anticipated success of therapeutic alternatives, Sanofi's ability to seize external growth opportunities, execute relevant transactions, and secure regulatory clearances, alongside risks concerning intellectual property and the outcomes of any related litigation. Moreover, fluctuating economic conditions, exchange rates, interest rates, and the ongoing impacts of COVID-19 on the global economy, customers, suppliers, and other stakeholders may present additional challenges that could adversely affect Sanofi’s business performance. The health crisis of COVID-19 continues to evolve, and further consequences may arise that we cannot currently foresee, possibly amplifying existing risks. The uncertainties discussed here are also detailed in the public filings made by Sanofi with the SEC and AMF, specifically noted under sections relating to “Risk Factors” and “Cautionary Statements Regarding Forward-Looking Statements” within Sanofi’s annual report filed on Form 20-F for the year concluding December 31, 2021. Sanofi does not commit to updating or revising any forward-looking information or statements except as mandated by law.
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