FX.co ★ Sanofi's Opella: FDA Lifts Clinical Hold On OTC Cialis Trial

Sanofi's Consumer Healthcare division, Opella, announced a positive development regarding its planned actual use trial (AUT) for Cialis (tadalafil). The U.S. Food and Drug Administration has lifted the clinical hold, allowing the trial to proceed as they explore transitioning Cialis from a prescription-only medication to an over-the-counter option. This marks a significant milestone for Cialis, as it becomes the first PDE-5 inhibitor to reach this stage.

Currently, Cialis (tadalafil) is available only by prescription in the United States. It is used in tablet form to treat erectile dysfunction (ED), the symptoms of benign prostatic hyperplasia (BPH), and a combination of both ED and BPH symptoms.