Sanofi and Eli Lilly and Company are pursuing regulatory approval for the switch of Cialis (tadalafil) for erectile dysfunction from prescription to over-the-counter status.
Cialis, an erectile dysfunction (ED) medication, is currently available by prescription only. Cialis was first approved by the European Medicines Agency in 2002, followed by the U.S. Food and Drug Administration (FDA) in 2003, for the treatment of ED.
Under the terms of the agreement, Sanofi acquires the exclusive rights to apply for approval of Cialis for over-the-counter (OTC) sales in the U.S., Europe, Canada, and Australia. Sanofi also holds exclusive rights to market Cialis OTC following Sanofi’s receipt of all necessary regulatory approvals. If approved, Sanofi anticipates providing Cialis OTC after the expiration of certain patents.
Vincent Warnery, senior vice president, Global Consumer Healthcare Division, Sanofi, said in a press statement, “This agreement provides us with an opportunity to work with Lilly, a leader in men’s health, to transform how this important medicine is offered to millions of men throughout the world.”
David Ricks, senior vice president, Lilly, and president, Lilly Bio-Medicines, said in the press statement, “Millions of men worldwide trust Cialis to treat ED. We are pleased to work with Sanofi to pursue a path that could allow more men who suffer from ED to obtain convenient access to a safe and reliable product without a prescription.
Ricks added,”Switching a medicine to over-the-counter is a highly regulated process that is data-driven and scientifically rigorous. Together with Sanofi, we look forward to working closely with regulatory authorities to define the proper actions and necessary precautions to help patients use over-the-counter Cialis appropriately.”
Steve Francesco, president and CEO of Francesco International, New York City, an expert in the Rx-to-OTC switch arena, told Healthline, “There have been attempts to take Viagra (sildenafil citrate) OTC. Pfizer made a filing to switch Viagra from Rx to OTC in Europe and they almost made it.”
Francesco went on to say that from a safety standpoint, Cialis is a better candidate for an Rx-to-OTC switch than Viagra. “Cialis is different from Viagra in that Cialis has a number of dosages, and presumably it would be the lower dose that would be switched. Cialis is considered to be safe and effective, and it has a much better side effect profile than Viagra.”
Pointing out that Cialis and Viagra were originally developed to treat high blood pressure, Francesco said one safety concern that would need to be addressed would be the risk for Cialis lowering blood pressure and causing serious health consequences, such as fainting, or being not as responsive when driving.
“If you are taking blood pressure medication, Cialis would be an additional blood pressure medication. As a prescription drug, doctors might prescribe Cialis and would tell a man, if they have an evening dose of some other blood pressure medication, that they should take Cialis instead,” explained Francesco.
In order for a switch to occur, the FDA determines whether the prescription requirements are necessary for the protection of the public health. The agency does this by looking at the product’s toxicity, the potential for harm, the method of use, and any other information needed to determine whether the drug is safe and effective for self-medication as directed in proposed labeling
While it remains to be seen whether the FDA will give the green light for Cialis to go OTC, Francesco pointed out that Cialis would have three years of marketing exclusivity in the OTC market, if the FDA does approve. “If it switches after the patent expires, that means the active ingredient could also be marketed by other companies. The companies will want it to switch to OTC just before the patent expires,” said Francesco.
Cialis’s patents are expected to expire between 2017 and 2020.