Sanofi reaches study milestone for Cialis

French pharma major Sanofi’s (Euronext; SAN) consumer healthcare business, Opella, has 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), for erectile dysfunction (ED), 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.