Sanofi's OTC Cialis Trial Halted by FDA Over Concerns in Study Design

Compiled by Fan Dongdong

Recently, the U.S. Food and Drug Administration (FDA) stated that due to concerning potential issues in the trial protocol design, the FDA has decided to immediately suspend the Actual Use Trial (AUT) for Sanofi's prescription drug Cialis (tadalafil) to be switched to over-the-counter status.

The U.S. FDA added that no patients have been recruited for Sanofi's AUT trial yet, and Sanofi also stated that it would continue to cooperate with the U.S. FDA to advance the Cialis program and invite the FDA to participate in meetings to discuss when determining the next steps.

Cialis was first approved by the European Medicines Agency (EMA) in 2002, and then by the U.S. FDA in 2003. However, now patients in the United States can only access Cialis treatment through a doctor's prescription.

Cialis is a tablet used to treat erectile dysfunction (ED) and the signs and symptoms of benign prostatic hyperplasia (BPH). Cialis is also the only PDE-5 inhibitor treatment that offers men more options when treating ED, as it can be taken on demand and only needs to be taken once daily.

In determining whether to allow the drug to be sold over-the-counter at pharmacy counters, the U.S. FDA needs to weigh whether patients can understand the complexity of their conditions and know exactly when to take the medication, ensuring patient safety in medication use.

Notably, similar to its competitor erectile dysfunction drugs (such as Viagra), if patients take Cialis together with nitrates (a class of heart medications including nitroglycerin), it may lead to the risk of a drop in blood pressure.

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

According to data analysis from market intelligence firm Coherant Market Insights, the global erectile dysfunction treatment market was estimated to be worth approximately $3.7 billion last year and is projected to grow to around $5.9 billion by 2028.

Reference Source:

1、FDA presses pause on trial for OTC version of anti-impotence drug Cialis

2、Update to Cialis: Rx-to-OTC Switch Actual

3、Polands Adamed Secures Tadalafil Rx-To-OTC Switch In World First