Opella Breaks New Ground with Over-the-Counter Cialis Study

Opella Achieves Milestone in Cialis OTC Transition

Opella, a part of Sanofi's Consumer Healthcare division, has recently made strides towards improving healthcare accessibility. The U.S. Food and Drug Administration (FDA) has lifted a clinical hold on Opella's planned actual use trial (AUT) for Cialis (tadalafil). This pivotal development enables Opella to move forward with its research aiming to transition Cialis from a prescription medication to an over-the-counter solution.

Understanding the Actual Use Trial

The AUT is designed to evaluate Cialis usage in real-world settings, which is essential for identifying any previously unrecognized issues. This trial will also confirm that consumers can adequately self-diagnose and manage their condition without the need for direct healthcare provider intervention. Such efforts are fundamental in reinforcing consumer empowerment and accessibility in medication usage.

Leadership Perspectives

Julie Van Ongevalle, President and CEO of Opella, stated, “We are delighted the FDA has completed its review and allowed us to initiate this important study. The AUT not only presents an excellent opportunity to gather essential insights on consumer use of Cialis, but it also highlights our dedication to advancing self-care solutions. This step represents our commitment to making self-care as straightforward as possible.”

Commitment to Consumer Safety

Dr. Josephine Fubara, Chief Science Officer of Opella, highlighted the importance of the FDA's decision as a significant advancement in transitioning Cialis to over-the-counter status. Dr. Fubara emphasized the importance of this trial in ensuring consumer safety and proper self-selection for using Cialis without a prescription. She expressed optimism about enhancing access for the numerous consumers who could benefit from Cialis in a nonprescription setting.

Advancing Self-Care Solutions

Opella is dedicated to progressing its development initiative aimed at introducing a new self-care option that has demonstrated effectiveness for those experiencing erectile dysfunction. The company is finalizing all necessary clinical and regulatory actions to initiate the AUT, with further details expected to be published on clinicaltrials.gov.

About Cialis: A Capable Treatment

Cialis (tadalafil) is currently available in the U.S. solely by prescription, primarily indicated for treating erectile dysfunction (ED) as well as the signs and symptoms of benign prostatic hyperplasia (BPH). Key features of Cialis include its unique availability options: it can be taken as needed or on a once-daily basis, providing men with flexibility in managing their treatment for ED.

Important Safety Information

It is crucial to note that Cialis is not advised for women or children. Furthermore, patients taking nitrates, commonly prescribed for chest pain, must avoid Cialis to prevent dangerous drops in blood pressure. Individuals should also refrain from using Cialis if allergic to tadalafil or any of its ingredients.

Overview of Sanofi

Sanofi is a globally recognized healthcare company committed to innovating and improving health outcomes. With a focus on delivering potentially life-altering treatment options and vaccines, Sanofi prioritizes sustainability and social responsibility in all endeavors. The company is listed on both EURONEXT: SAN and NASDAQ: SNY.

Media and Investor Relations

For any inquiries related to Opella Media Relations, contact Justine Rohée at +33 6 86 47 85 60 or via email. For investor relations with Sanofi, Thomas Kudsk Larsen can be reached at +44 7545 513 693.

Frequently Asked Questions

What is Opella's recent milestone regarding Cialis?

Opella has received FDA approval to initiate an actual use trial to transition Cialis from a prescription to an over-the-counter medication.

What is the purpose of the Actual Use Trial (AUT)?

The AUT is designed to evaluate how Cialis is used in real-world scenarios and ensure consumers can safely manage their treatment without requiring a prescription.

Who are the key figures in Opella?

Julie Van Ongevalle serves as the President and CEO, while Dr. Josephine Fubara holds the position of Chief Science Officer.

What are Cialis's indications for use?

Cialis is indicated for the treatment of erectile dysfunction and the symptoms of benign prostatic hyperplasia (BPH).

Where can I find more information about the Actual Use Trial?

Further details about the study and other relevant information will be available on clinicaltrials.gov soon.

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