Buying the erectile dysfunction drug Cialis may soon be as easy as buying snacks, soda drinks and condoms from the drug store as Cialis maker Eli Lilly and pharmaceutical company Sanofi announced on Wednesday that they have agreed to seek permission from health regulators to sell the drug without prescription.
Cialis, one of the best-selling anti-impotence drugs worldwide, is currently only available by prescription. The tablet, which got the approval as treatment for erectile dysfunction from the European Medicines Agency (EMA) in 2002 and from the U.S Food and Drug Administration (FDA) a year after, is currently one of Eli Lilly's most successful products.
Since its launch, Cialis has been used by more than 45 million men worldwide. It has also already generated over $14 billion in global sales and in 2013 alone, generated more than $2 billion in sales worldwide.
Besides being prescribed for men suffering from erectile dysfunction, a condition when a man is no longer able to develop or keep an erection during sexual intercourse, Cialis is also approved as treatment for enlarged prostate glands. A study published in the journal Neurology earlier this month also suggests that the drug, along with Viagra, can potentially help boys suffering from Duchenne muscular dystrophy, a hereditary and currently incurable disease that is characterized by the weakening of the muscles. Individuals with the condition often die at an early age.
Under Eli Lilly and Sanofi's agreement, Sanofi obtains the exclusive rights to apply for the approval of Cialis over the counter in the U.S., Europe, Australia and Canada albeit it remains uncertain if drug regulators will allow the drug to be sold without prescription given the side effects and potential risks of using the tablet. Cialis, for instance, can lower blood pressure to a dangerous level if the drug is taken with medicines called nitrates, which are often used for treating chest pain.
Eli Lilly and Sanofi officials said that once over the counter Cialis becomes available, men with impotency problems can have easier access to treatment. Making the drug available over the counter can also reduce the sale of bogus and stolen Cialis on the internet.
"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," said Lilly senior vice president David Ricks. "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."
