US FDA Lifts Hold on Sanofi's Trial to Make Cialis Available Over-the-Counter

Opella, the Consumer Healthcare division of Sanofi, announced that the US Food and Drug Administration (FDA) has removed a clinical hold on its proposed actual use trial (AUT) aimed at facilitating the transition of Cialis (tadalafil) from prescription status to over-the-counter availability. This choice permits the commencement of the AUT and positions Cialis as the initial PDE-5 inhibitor to reach this significant milestone.

AUTs assess the application of the medication in real-life situations to uncover any previously unrecognized problems and to verify that individuals can accurately self-diagnose and manage their treatment independently without requiring assistance from a healthcare professional.

Julie Van Ongevalle, president and CEO, Opella, said: “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, said: “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 non-prescription Cialis.”