OTC version of anti-impotence drug Cialis trial paused by FDA

Cialis can cause a dangerous fall in blood pressure if taken with nitrates, a class of heart drugs.



According to Sanofi , a trial evaluating switching the prescription-only erectile dysfunction drug Cialis to an over the counter (OTC) treatment has been placed on hold by the United States (U.S.) Food and Drug Administration (FDA). The pause is due to worries about how the trial protocol was constructed, according to the business, which also stated that no patients have been enrolled for the study as of yet. Cialis, also known as tadalafil, was approved as a prescription-only therapy by the European Medicines Agency (EMA) in 2002 and the U.S. FDA in 2003. The therapy, which made inventor Eli Lilly billions before generic competition undercut sales, stands out from the competition because of its time-release formula, which allows men to take it up to 36 hours before using it.


Sanofi was awarded the rights to sell Cialis as a non-prescription drug in the United States, Europe, Canada, and Australia in 2014 ,once regulatory approvals have been secured in each region. According to a corporate executive last year, this OTC version of Cialis will be a key contributor to Sanofi's consumer health segment attaining above-market growth from 2024. The FDA considers whether patients can grasp complex features of their disease and when to take the treatment to ensure safe use when deciding whether to allow prescription drugs to be supplied over the counter. Cialis, like other anti-impotence medications like Viagra, can induce a hazardous drop in blood pressure when combined with nitrates, such include nitroglycerine.