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 informed Sanofi that its planned Actual Use Trial (AUT) to support the Rx-to-OTC switch for Cialis® (tadalafil) has been placed on clinical hold due to matters surrounding the protocol design. Sanofi’s AUT has not yet recruited any patients. Sanofi continues to work diligently with the FDA to advance the Cialis® program and will proactively engage with the Agency in forthcoming meetings as we cautiously determine the necessary next steps. This collaboration is crucial, as the successful transition from prescription to over-the-counter availability hinges on positive outcomes from these trials and clear communication with regulatory authorities.
About Cialis
Currently only available with a prescription, Cialis is a well-established tablet that is prescribed to treat erectile dysfunction (ED), the signs and symptoms associated with benign prostatic hyperplasia (BPH), and to address both ED and the complications of BPH simultaneously. Cialis is recognized as the only PDE-5 inhibitor treatment that offers men a flexible choice, allowing them to opt for either on-demand use or a once-daily regimen tailored to their lifestyle. For further insights and comprehensive information about Cialis, including dosing and usage guidelines, please visit the official website at www.cialis.com.
It is imperative to note that Cialis is not indicated for women or children. Patients must be aware that Cialis should not be co-administered with certain medications, specifically those categorized as nitrates, such as isosorbide dinitrate or isosorbide mononitrate, which are frequently prescribed for chest pain management. Additionally, recreational substances known as "poppers," including amyl or butyl nitrite, must be avoided, as their combination with Cialis may lead to a dangerously low drop in blood pressure. It is also essential for individuals who may have a known allergy to Cialis or Adcirca® (tadalafil), or any components within these medications, to refrain from using Cialis. Anyone experiencing symptoms indicative of an allergic reaction, such as a rash, hives, swelling of facial regions, or any difficulties in breathing or swallowing, should seek immediate medical assistance without delay.
About Sanofi
We are an innovative global healthcare company, driven by one purposeful mission: to relentlessly pursue the miracles of science in our quest to enhance the lives of individuals around the world. Our dedicated team spans approximately 100 countries, tirelessly transforming the practice of medicine with a shared goal of turning what may seem impossible into a tangible reality. We offer potentially life-altering treatment options and life-saving vaccines to millions on a global scale, while prioritizing sustainability and social responsibility at the core of our ambitions. Our commitment to public health and well-being remains unwavering.
Sanofi is publicly listed on EURONEXT: SAN and NASDAQ: SNY
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