Opella reaches study milestone for Cialis
January 21, 2025 – Clinical Trials, Other, Pharmaceutical – FDA, Opella, PDE-5 inhibitor, Sanofi, clinical trials
21 January 2025 — Paris, France — 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 Ongevalle, President 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 Fubara, Chief 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 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. Visit: www.sanofi.com/en.
