Opella, the consumer healthcare business of French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Tuesday that the US Food and Drug Administration (FDA) has lifted a clinical hold on its planned actual use trial (AUT) for Cialis (tadalafil).

This allows for the initiation of the AUT, a crucial step in the process of making Cialis available over-the-counter.

Cialis is the first PDE-5 inhibitor to reach this milestone.

The AUT will evaluate the use of Cialis under real-world conditions to ensure consumer safety and appropriate self-treatment.

Opella said that it is committed to completing the necessary activities to begin the pivotal AUT.

Sanofi and CD&R recently announced the intention to transfer a 50% controlling stake in Opella to CD&R, with Sanofi remaining a significant shareholder.

Cialis is currently available in the United States only by prescription to treat erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia.