FDA Puts Hold on Trial for Cialis OTC

The regulatory agency indicated there is an issue surrounding the protocol design.

The FDA has put a clinical hold on a trial to support the Rx-to-OTC switch for Cialis (tadalafil) because of an issue related to the protocol design. Sanofi’s Actual Use Trial (AUT) has not yet recruited any patients.

The Actual Use Trial design uses a real-world setting to assess the ability of consumers to use a product in an over-the-counter setting according to the proposed product labeling. This is key in applications for switching medications to nonprescription use.

Sanofi said in a statement that it continues to work with the FDA to move the Cialis program forward.

Lilly, which developed Cialis, signed an agreement with Sanofi in 2014 for the nonprescription development of Cialis.

The FDA approved Cialis in 2003 to treat men with erectile dysfunction, as well as the signs and symptoms of benign prostatic hyperplasia (BPH). The global erectile dysfunction treatment market is estimated to be valued at $3.68 billion in 2021 and is expected to exhibit a CAGR of 7.1% from 2021 to 2028, according to a report by Coherent Market Insights.

Pfizer’s Viagra (sildenafil) was approved for nonprescription used in the United Kingdom in 2017 and launched in that market in 2018, the world’s first OTC erectile dysfunction product. It is not available as a nonprescription product in the United States.

This year so far, the FDA has approved one therapy to make switch to OTC status: Nasonex 24 Hour allergy, which was approved in March 2022.