U.S. FDA Halts Sanofi's Cialis Over-the-counter Drug Trial Amid Doubts Over Program Design

A few days ago, the U.S. Food and Drug Administration (FDA) said it has decided to immediately suspend the actual use trial of Sanofi’s prescription drug Cialis (tadalafil) converted to an over-the-counter drug due to worrying potential problems with the design of the trial protocol ( AUT) experimental design work.

The U.S. FDA added that the Sanofi AUT trial has not yet recruited any patients, and Sanofi also said it will continue to work with the U.S. FDA to advance the Cialis program, and will invite the FDA to participate in meeting discussions when determining next steps.

Cialis was first approved by the European Medicines Agency (EMA) in 2002 and then by the US FDA in 2003. But right now, U.S. patients can only get Cialis treatment with a doctor's prescription.

Cialis is a tablet used to treat the signs and symptoms of erectile dysfunction (ED) and benign prostatic hyperplasia (BPH). At the same time, Cialis is also the only PDE-5 inhibitor therapy that can provide male patients with more options in the treatment of erectile dysfunction. The drug can be used on demand, and Cialis only needs to be used once a day.

In determining whether to allow the drug to be sold over-the-counter in a pharmacy, the FDA needs to weigh whether patients can understand the complexities of their condition and know exactly when they should take the drug to ensure their safety.

It's worth noting that, like the drug's rival anti-impotence drugs (such as Viagra), taking Cialis with nitrates (a class of heart drugs that includes nitroglycerin) puts patients at risk for a drop in blood pressure .

In March 2022, Poland became the first country in the world to allow the purchase of tadalafil for erectile dysfunction without a prescription, thanks to the successful completion of the drug by Polish manufacturer AdamedPharma from prescription drugs (Rx ) to over-the-counter (OTC) conversion.

The global erectile dysfunction treatment market was estimated to be worth about $3.7 billion last year and is expected to grow to about $5.9 billion by 2028, according to analysis by market intelligence firm Coherant Market Insights.