Sanofi’s Trial to Make Cialis Available Over-the-Counter Meets FDA Hold

The FDA has imposed a clinical hold on Sanofi’s actual use trial (AUT) that evaluates switching Cialis (tadalafil), a prescription-only medication for erectile dysfunction, to an over-the-counter version. The reason for the pause appears to be related to the protocol design of the trial. 

The AUT has yet to recruit any patients. Sanofi will continue to work with the FDA to resolve the hold, said the company. 

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A Popular Prescription Treatment for Erectile Dysfunction

Cialis (tadalafil) is one of the most popular prescription medications for erectile dysfunction. The drug was first approved by the European Medicines Agency in 2002. An approval from the US FDA followed in 2003. 

Cialis is a PDE-5 inhibitor, a type of medication that causes vasodilation and improves blood flow to tissues such as the tissue of the penis. It works by inhibiting the PHE-5 enzyme found in the smooth muscle cells of blood vessels. 

In 2014, Sanofi bought exclusive rights to market the OTC version of Cialis from Eli Lilly. The French drugmaker planned to apply for OTC approval in the US, Australia, Canada, and Europe once the drug patent expired in 2018. 

While rival medication Viagra has made the switch to OTC in the UK (but not the US), Cialis remains a prescription medicine. The drug may be well-tolerated, with common side effects being headaches, nasopharyngitis, muscle aches, and back pain, but concerns exist over the potential of misuse and drug interactions. 

Like Viagra, Cialis has the potential to lower blood pressure to dangerous levels, and cannot be taken with nitrates such as chest pain medications or recreational drugs such as amyl or butyl nitrite. It is also not for women or children. 

The FDA’s process for transferring prescription drugs to OTC status is rigorous and highly regulated. For Cialis to be granted OTC status, it must have a wide safety margin, be effective, and be labeled clearly to ensure proper use.

Author

Joy Lin

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