Sanofi's effort to switch erectile dysfunction pill Cialis to over-the-counter (OTC) availability from its original prescription status has been slowed to a grinding halt with the FDA’s decision to put a trial on hold.
The FDA halted an "actual use trial" intended to study the potential switch over problems with protocol design, Sanofi said in a statement. The trial has not yet recruited patients. The FDA has a detailed process when deciding allowance of a drug’s switch from prescription to OTC.
Patients must understand all the aspects of their condition and know when to take the drug to ensure safe use. Cialis may cause an unsafe drop in blood pressure when taking nitrates (often prescribed for chest pain) or recreational drugs such as poppers.
Sanofi snagged exclusive rights to licensing the drug on a nonprescription basis in the U.S., Europe, Canada and Australia from Eli Lilly back in 2014. The erectile dysfunction (ED) drug was approved by the FDA in 2003 and gained approval in more than 120 counties for varied indications, including benign prostastic hyperplasia.
The drugmaker has put a lot of weight on the Cialis OTC switch to drive growth in its consumer health division amid a years-long turnaround effort by CEO Paul Hudson.
Sanofi’s consumer healthcare division pulled in 4.5 billion euros last year, a 5% increase from 2020.