Opella's Cialis Milestone: A Step Towards Over-the-Counter Availability

Opella, Sanofi's Consumer Healthcare business, has reached a significant milestone in its quest to make Cialis (tadalafil) available over-the-counter (OTC). The US Food and Drug Administration (FDA) has lifted a clinical hold on the planned actual use trial (AUT) to support the switch of Cialis from a prescription to an OTC medicine. This decision allows for the initiation of the AUT and makes Cialis the first PDE-5 inhibitor to achieve this milestone.

The 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 of Opella, expressed her enthusiasm about the FDA's decision, stating that the actual use trial is not only a significant opportunity to gain insights into how Cialis is used by consumers without a prescription but also underscores the company's commitment to advancing self-care solutions. It represents a crucial step towards Opella's commitment to make self-care as simple as it should be.

Dr. Josephine Fubara, Chief Science Officer of Opella, highlighted the significance of the FDA's decision, noting that it 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 its thorough review of the company's data, Opella 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 OTC use. 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 partnership between Sanofi and CD&R, involving the transfer of a 50% controlling stake in Opella, is expected to support the company's growth and development. With 11,000 talented and passionate people bringing iconic brands to life, Opella is poised to ignite a new bold development journey. Sanofi will become a focused science-driven biopharma delivering innovative medicines and vaccines to patients, while Opelli will become a global consumer healthcare champion.