The companies Sanofi and Eli Lilly and Company plan to pursue a nonprescription Cialis option for men suffering from erectile dysfunction (ED).
"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," Vincent Warnery, senior vice president, Global Consumer Healthcare Division, Sanofi, said in an Eli Lilly and Company new release . "The opportunity to forge an industry-leading partnership that adds to Sanofi Consumer Healthcare's leading portfolio and successful track record of over-the-counter switches reinforces consumer health care as a major growth platform for Sanofi."
The drug is currently only available with a prescription and is used to treat men with symptoms of ED.
"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," David Ricks, senior vice president, Lilly, and president, Lilly Bio-Medicines, said in the news release. "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."
Cialis was first approved by the European Medicines Agency in 2002 and by the U.S. Food and Drug Administration in 2003. The drug is now approved in 120 countries .
Cialis is not meant for women or children and should not be taken with nitrates that are prescribed for chest pain including isosorbide dinitrate or isosorbide mononitrate. Taking it with "poppers" or amyl or butyl nitrite could cause dangerous drops in blood pressure. Anyone who has an allergic reaction to the drug is urged to contact their medical provider immediately.
