BRIEF— FDA slaps clinical hold on Rx-to-OTC switch for Cialis

The US Food and Drug Administration has informed French pharma major Sanofi that its planned Actual Use Trial (AUT) to support the Rx-to-OTC switch for Cialis (tadalafil) has been placed on clinical hold due to matters surrounding the protocol design.

Sanofi’s AUT has not yet recruited any patients.

Sanofi says it continues to work with the FDA to move the Cialis program forward and will engage the agency in upcoming meetings as it determines next steps.

About Cialis

Currently only available with a prescription from US pharma Eli Lilly, Cialis is a tablet taken to treat erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and both ED and the signs and symptoms of BPH.

Cialis is the only PDE-5 inhibitor treatment that offers men a choice when it comes to treatment for erectile dysfunction - Cialis for use as needed and Cialis for once daily use.

Sanofi acquired the exclusive rights to apply for approval of Cialis OTC in the USA, Europe, Canada and Australia from Lilly on 2014.